| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 03760154008907 | FIXIT Knotless threaded anchor | EPAV245KNO | Knotless threaded anchor for single interference in rotator cuff repair - Ø 4.5 Knotless threaded anchor for single interference in rotator cuff repair - Ø 4.5 mm, Length 11.25 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 2 | 03760154008921 | FIXIT Knotless threaded anchor | EPAV265KNO | Knotless threaded anchor for single interference in rotator cuff repair - Ø 6.5 Knotless threaded anchor for single interference in rotator cuff repair - Ø 6.5 mm, Length 14 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 3 | 03760154008914 | FIXIT Knotless threaded anchor | EPAV255KNO | Knotless threaded anchor for single interference in rotator cuff repair - Ø 5.5 Knotless threaded anchor for single interference in rotator cuff repair - Ø 5.5 mm, Length 14 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 4 | 03760154008884 | FIXIT Threaded anchor system | EPA0065CLA | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 6.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 5 | 03760154008860 | FIXIT Threaded anchor system | EPA0055CLA | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 5.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 6 | 03760154008846 | FIXIT Threaded anchor system | EPA0047CLA | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.7 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 7 | 03760304680502 | NON STERILE SAMPLE - NOT FOR IMPLANTATION | 292004 | The RIGIDLOOP adjustable juxtacortical fixation device consists of an adjustable The RIGIDLOOP adjustable juxtacortical fixation device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. THE SAMPLE IS NON-STERILE, NOT INTENDED FOR IMPLANTATION. | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | RIGIDLOOP Multilig Adjustable Cortical Button |
| 8 | 03760154008976 | Adjustable juxtacortical fixation device for cortical tunnel = Ø 5 to 10 mm | PULXL21202 | The Pullup® adjustable juxtacortical fixation device consists of an adjustable n The Pullup® adjustable juxtacortical fixation device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. The implant is supplied sterile, ready to use. | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | PULLUP |
| 9 | 03760154008969 | Adjustable juxtacortical fixation device for cortical tunnel = Ø 4.5 mm | PULLU21201 | The Pullup® adjustable juxtacortical fixation device consists of an adjustable n The Pullup® adjustable juxtacortical fixation device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. The implant is supplied sterile, ready to use. | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | PULLUP |
| 10 | 03760154008280 | Suture Anchor Punch Tap | 110026112 | Ø 5.5 mm & Ø 6.5 mm suture anchor punch tap | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 11 | 03760154008273 | Suture Anchor Punch Tap | 110026111 | Ø4.5 mm suture anchor punch tap | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 12 | 03760154008266 | Double loaded BroadBand suture anchor | 110026110 | Threaded anchor system Ø 6.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 13 | 03760154008259 | Double loaded BroadBand suture anchor | 110026109 | Threaded anchor system Ø 5.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 14 | 03760154008242 | Double loaded BroadBand suture anchor | 110026108 | Threaded anchor system Ø 4.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 15 | 03760154008235 | Double loaded MaxBraid suture anchor | 110026107 | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 6.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 16 | 03760154008228 | Double loaded MaxBraid suture anchor | 110026106 | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 5.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 17 | 03760154008211 | Double loaded MaxBraid suture anchor | 110026105 | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 18 | 03760154007245 | Non-sliding BroadBand | 110026115 | Threaded anchor system Ø 6.5 mm with one Blue non-sliding suture and one White/G Threaded anchor system Ø 6.5 mm with one Blue non-sliding suture and one White/Green sliding suture | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 19 | 03760154007238 | Non-sliding BroadBand | 110026114 | Threaded anchor system Ø 5.5 mm with one Blue non-sliding suture and one White/G Threaded anchor system Ø 5.5 mm with one Blue non-sliding suture and one White/Green sliding suture | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 20 | 03760154007221 | Non-sliding BroadBand | 110026113 | Threaded anchor system Ø 4.5 mm with one Blue non-sliding suture and one White/G Threaded anchor system Ø 4.5 mm with one Blue non-sliding suture and one White/Green sliding suture | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 21 | 03760154007924 | Screw for OTIS-C PLUS plate fixation | EVO9066080 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 22 | 03760154005142 | OTIS-C PLUS Plate - Right | EVO9067522 | 316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be use 316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be used with OTIS-C Plus screws. | HRS | Plate, Fixation, Bone | 2 | OTIS-C PLUS |
| 23 | 03760154005135 | OTIS-C PLUS Plate - Left | EVO9067722 | 316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be use 316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be used with OTIS-C Plus screws. | HRS | Plate, Fixation, Bone | 2 | OTIS-C PLUS |
| 24 | 03760154004794 | NON STERILE OTIS-C PLUS Plate | EVONS67622 | NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate. | HRS | Plate, Fixation, Bone | 2 | OTIS-C PLUS |
| 25 | 03760154004770 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66027 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 26 | 03760154004756 | NON STERILE OTIS-C PLUS Left Plate | EVONS67722 | NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate. | HRS | Plate, Fixation, Bone | 2 | OTIS-C PLUS |
| 27 | 03760154004749 | NON STERILE OTIS-C PLUS Right Plate | EVONS67522 | NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate. | HRS | Plate, Fixation, Bone | 2 | OTIS-C PLUS |
| 28 | 03760154004732 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66030 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 29 | 03760154004718 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66050 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 30 | 03760154004701 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66036 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 31 | 03760154004695 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66033 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 32 | 03760154004497 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66055 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 33 | 03760154004480 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66065 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 34 | 03760154004459 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66039 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 35 | 03760154004190 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66060 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 36 | 03760154004169 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66042 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 37 | 03760154004152 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66070 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS p NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 38 | 03760154004145 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66045 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 39 | 03760154001397 | Screw for OTIS-C PLUS plate fixation | EVO9066075 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 40 | 03760154001281 | Screw for OTIS-C PLUS plate fixation | EVO9066070 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 41 | 03760154001274 | Screw for OTIS-C PLUS plate fixation | EVO9066065 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 42 | 03760154001267 | Screw for OTIS-C PLUS plate fixation | EVO9066060 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 43 | 03760154001250 | Screw for OTIS-C PLUS plate fixation | EVO9066055 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 44 | 03760154001243 | Screw for OTIS-C PLUS plate fixation | EVO9066050 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 45 | 03760154001236 | Screw for OTIS-C PLUS plate fixation | EVO9066045 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 46 | 03760154001229 | Screw for OTIS-C PLUS plate fixation | EVO9066042 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 47 | 03760154001212 | Screw for OTIS-C PLUS plate fixation | EVO9066039 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 48 | 03760154001205 | Screw for OTIS-C PLUS plate fixation | EVO9066036 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 49 | 03760154001199 | Screw for OTIS-C PLUS plate fixation | EVO9066033 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 50 | 03760154001175 | Screw for OTIS-C PLUS plate fixation | EVO9066027 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | M684180803071 | 18080307 | 18080307 | CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 5.0cm LENGTH | Advantim | MICROPORT ORTHOPEDICS INC. |
| 2 | M684180803061 | 18080306 | 18080306 | CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 4.5cm LENGTH | Advantim | MICROPORT ORTHOPEDICS INC. |
| 3 | M68418080305WD1 | 18080305WD | 18080305WD | CANCL 6.5MM BONE SCREW 4.0CM SELF TAPPING IMPLANT PARTNERS™ | Implant Partners | MICROPORT ORTHOPEDICS INC. |
| 4 | M684180803051 | 18080305 | 18080305 | CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 4.0cm LENGTH | Advantim | MICROPORT ORTHOPEDICS INC. |
| 5 | M68418080304WD1 | 18080304WD | 18080304WD | CANCL 6.5MM BONE SCREW 3.5CM SELF TAPPING IMPLANT PARTNERS™ | Implant Partners | MICROPORT ORTHOPEDICS INC. |
| 6 | M684180803041 | 18080304 | 18080304 | CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 3.5cm LENGTH | Advantim | MICROPORT ORTHOPEDICS INC. |
| 7 | M68418080303WD1 | 18080303WD | 18080303WD | CANCL 6.5MM BONE SCREW 3.0CM SELF TAPPING IMPLANT PARTNERS™ | Implant Partners | MICROPORT ORTHOPEDICS INC. |
| 8 | M684180803031 | 18080303 | 18080303 | CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 3.0cm LENGTH | Advantim | MICROPORT ORTHOPEDICS INC. |
| 9 | M68418080302WD1 | 18080302WD | 18080302WD | CANCL 6.5MM BONE SCREW 2.5CM SELF TAPPING IMPLANT PARTNERS™ | Implant Partners | MICROPORT ORTHOPEDICS INC. |
| 10 | M684180803021 | 18080302 | 18080302 | CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 2.5cm LENGTH | Advantim | MICROPORT ORTHOPEDICS INC. |
| 11 | M68418080301WD1 | 18080301WD | 18080301WD | CANCL 6.5MM BONE SCREW 2.9CM SELF TAPPING IMPLANT PARTNERS™ | Implant Partners | MICROPORT ORTHOPEDICS INC. |
| 12 | M684180803011 | 18080301 | 18080301 | CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 2.0cm LENGTH | Advantim | MICROPORT ORTHOPEDICS INC. |
| 13 | M68418080300WD1 | 18080300WD | 18080300WD | CANCL 6.5MM BONE SCREW 1.5CM SELF TAPPING IMPLANT PARTNERS™ | Implant Partners | MICROPORT ORTHOPEDICS INC. |
| 14 | M684180803001 | 18080300 | 18080300 | CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 1.5cm LENGTH | Advantim | MICROPORT ORTHOPEDICS INC. |
| 15 | M621OW30LBS26MM0 | GM-500-26 | OW3.0LBS-26MM | osteo-WEDGE 3.0mm x 26mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 26mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 3.0mm x 26mm Locking Bone Screw | GRAMEDICA |
| 16 | M621OW30LBS24MM0 | GM-500-24 | OW3.0LBS-24MM | osteo-WEDGE 3.0mm x 24mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 24mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 3.0mm x 24mm Locking Bone Screw | GRAMEDICA |
| 17 | M621OW30LBS22MM0 | GM-500-22 | OW3.0LBS-22MM | osteo-WEDGE 3.0mm x 22mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 22mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 3.0mm x 22mm Locking Bone Screw | GRAMEDICA |
| 18 | M621OW30LBS20MM0 | GM-500-20 | OW3.0LBS-20MM | osteo-WEDGE 3.0mm x 20mm Locking Bone Screw. For use with the osteo-WEDGE Openi osteo-WEDGE 3.0mm x 20mm Locking Bone Screw. For use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 3.0mm x 20mm Locking Bone Screw | GRAMEDICA |
| 19 | M621OW30LBS18MM0 | GM-500-18 | OW3.0LBS-18MM | osteo-WEDGE 3.0mm x 18mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 18mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 3.0mm x 18mm Locking Bone Screw | GRAMEDICA |
| 20 | M621OW30LBS16MM0 | GM-500-16 | OW3.0LBS-16MM | osteo-WEDGE 3.0mm x 16mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 16mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 3.0mm x 16mm Locking Bone Screw | GRAMEDICA |
| 21 | M621OW30LBS14MM0 | GM-500-14 | OW3.0LBS-14MM | osteo-WEDGE 3.0mm x 14mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 14mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 3.0mm x 14mm Locking Bone Screw | GRAMEDICA |
| 22 | M621OW30LBS12MM0 | GM-500-12 | OW3.0LBS-12MM | osteo-WEDGE 3.0mm x 12mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 12mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 3.0mm x 12mm Locking Bone Screw | GRAMEDICA |
| 23 | M621OW30LBS10MM0 | GM-500-10 | OW3.0LBS-10MM | osteo-WEDGE 3.0mm x 10mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 10mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 3.0mm x 10mm Locking Bone Screw | GRAMEDICA |
| 24 | M621OW30LBS08MM0 | GM-500-08 | OW3.0LBS-08MM | osteo-WEDGE 3.0mm x 08mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 08mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 3.0mm x 08mm Locking Bone Screw | GRAMEDICA |
| 25 | M621OW25LBS22MM0 | GM-200-22 | OW2.5LBS-22MM | osteo-WEDGE 2.5mm x 22mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 2.5mm x 22mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 2.5mm x 22mm Locking Bone Screw | GRAMEDICA |
| 26 | M621OW25LBS20MM0 | GM-200-20 | OW2.5LBS-20MM | osteo-WEDGE 2.5mm x 20mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 2.5mm x 20mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 2.5mm x 20mm Locking Bone Screw | GRAMEDICA |
| 27 | M621OW25LBS18MM0 | GM-200-18 | OW2.5LBS-18MM | osteo-WEDGE 2.5mm x 18mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 2.5mm x 18mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 2.5mm x 18mm Locking Bone Screw | GRAMEDICA |
| 28 | M621OW25LBS16MM0 | GM-200-16 | OW2.5LBS-16MM | osteo-WEDGE 2.5mm x 16mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 2.5mm x 16mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 2.5mm x 16mm Locking Bone Screw | GRAMEDICA |
| 29 | M621OW25LBS14MM0 | GM-200-14 | OW2.5LBS-14MM | osteo-WEDGE 2.5mm x 14mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 2.5mm x 14mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 2.5mm x 14mm Locking Bone Screw | GRAMEDICA |
| 30 | M621OW25LBS12MM0 | GM-200-12 | OW2.5LBS-12MM | osteo-WEDGE 2.5mm x 12mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 2.5mm x 12mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 2.5mm x 12mm Locking Bone Screw | GRAMEDICA |
| 31 | M621OW25LBS10MM0 | GM-200-10 | OW2.5LBS-10MM | osteo-WEDGE 2.5mm x 10mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 2.5mm x 10mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 2.5mm x 10mm Locking Bone Screw | GRAMEDICA |
| 32 | M621OW25LBS08MM0 | GM-200-08 | OW2.5LBS-08MM | osteo-WEDGE 2.5mm x 08mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 2.5mm x 08mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE 2.5mm x 08mm Locking Bone Screw | GRAMEDICA |
| 33 | M621OW24TT12MM0 | GM-100-12 | OW2.4TT-12MM | osteo-WEDGE Temporary Tack, 2.4mm x 12mm. Non-sterile single use (disposable) a osteo-WEDGE Temporary Tack, 2.4mm x 12mm. Non-sterile single use (disposable) accessory for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations. | osteo-WEDGE Temporary Tack 2.4mm x 12mm | GRAMEDICA |
| 34 | M621HYPINSTRAY0 | HYP-INS-TRAY | HYP-INS-TRAY | HyProCure (reusable) Instrument Set. The instrument set contains six Trial Sizer HyProCure (reusable) Instrument Set. The instrument set contains six Trial Sizers (05mm thru 10mm), one Driver and three Guide Wires. For use with the HyProCure Sinus Tarsi Implant system. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion. | HyProCure Instrument Set | GRAMEDICA |
| 35 | M621HYPIITS120 | HYP II-TS-12 | HYP II-TS-12 | HyProCure II Trial Sizer 12 instrument. For use with the HyProCure II Sinus Tar HyProCure II Trial Sizer 12 instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Trial Sizer 12 | GRAMEDICA |
| 36 | M621HYPIITS110 | HYP II-TS-11 | HYP II-TS-11 | HyProCure II Trial Sizer 11 instrument. For use with the HyProCure II Sinus Tar HyProCure II Trial Sizer 11 instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.. | HyProCure II Trial Sizer 11 | GRAMEDICA |
| 37 | M621HYPIITS100 | HYP II-TS-10 | HYP II-TS-10 | HyProCure II Trial Sizer 10 instrument. For use with the HyProCure II Sinus Tar HyProCure II Trial Sizer 10 instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Trial Sizer 10 | GRAMEDICA |
| 38 | M621HYPIITS090 | HYP II-TS-09 | HYP II-TS-09 | HyProCure II Trial Sizer 09 instrument. For use with the HyProCure II Sinus Tar HyProCure II Trial Sizer 09 instrument. For use with the HyProCure II Sinus Tarsi Implants. The HyProCure II (HYP II and HYP IIs) Sinus Tarsi Implant system is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Trial Sizer 09 | GRAMEDICA |
| 39 | M621HYPIITS080 | HYP II-TS-08 | HYP II-TS-08 | HyProCure II Trial Sizer 08 instrument. For use with the HyProCure II Sinus Tar HyProCure II Trial Sizer 08 instrument. For use with the HyProCure II Sinus Tarsi Implants. The HyProCure II (HYP II and HYP IIs) Sinus Tarsi Implant system is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Trial Sizer 08 | GRAMEDICA |
| 40 | M621HYPIITS070 | HYP II-TS-07 | HYP II-TS-07 | HyPrHyProCure II Trial Sizer 07 instrument. For use with the HyProCure II Sinus HyPrHyProCure II Trial Sizer 07 instrument. For use with the HyProCure II Sinus Tarsi Implants. The HyProCure II (HYP II and HYP IIs) Sinus Tarsi Implant system is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Trial Sizer 07 | GRAMEDICA |
| 41 | M621HYPIITS060 | HYP II-TS-06 | HYP II-TS-06 | HyProCure II Trial Sizer 06 instrument. For use with the HyProCure II Sinus Tar HyProCure II Trial Sizer 06 instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Trial Sizer 06 | GRAMEDICA |
| 42 | M621HYPIIPS0 | HYPII-PS | HYPII-PS | HyProCure II Positioning Sleeve instrument. For use with the HyProCure II Sinus HyProCure II Positioning Sleeve instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Positioning Sleeve | GRAMEDICA |
| 43 | M621HYPIIINSTRAY0 | HYPII-INS-TRAY | HYPII-INS-TRAY | HyProCure II (reusable) Instrument Tray-Kit. The Instrument kit contains seven HyProCure II (reusable) Instrument Tray-Kit. The Instrument kit contains seven Trial Sizers (06mm thru 12mm) one Driver, one Positioning Sleeve and three Guide Wires). For use with the HyProCure II Sinus Tarsi Implants. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion | HyProCure II Instrument Tray-Set | GRAMEDICA |
| 44 | M621HYPII50 | HYP II-5 | HYP II-5 | HyProCure II Driver instrument. For use with the HyProCure II Sinus Tarsi Impla HyProCure II Driver instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Driver | GRAMEDICA |
| 45 | M621HYPII120 | HYP II-12 | HYP II-12 | HyProCure II Sinus Tarsi Implant Size 12. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 12. Indications: HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Sinus Tarsi Stent Size 12 | GRAMEDICA |
| 46 | M621HYPII110 | HYP II-11 | HYP II-11 | HyProCure II Sinus Tarsi Implant Size 11. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 11. Indications: HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Sinus Tarsi Stent Size 11 | GRAMEDICA |
| 47 | M621HYPII100 | HYP II-10 | HYP II-10 | HyProCure II Sinus Tarsi Implant Size 10. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 10. Indications: HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Sinus Tarsi Stent Size 10 | GRAMEDICA |
| 48 | M621HYPII090 | HYP II-09 | HYP II-09 | HyProCure II Sinus Tarsi Implant Size 09. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 09. Indications: HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Sinus Tarsi Stent Size 09 | GRAMEDICA |
| 49 | M621HYPII080 | HYP II-08 | HYP II-08 | HyProCure II Sinus Tarsi Implant Size 08. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 08. Indications: HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Sinus Tarsi Stent Size 08 | GRAMEDICA |
| 50 | M621HYPII070 | HYP II-07 | HYP II-07 | HyProCure II Sinus Tarsi Implant Size 07. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 07. Indications: HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. | HyProCure II Sinus Tarsi Stent Size 07 | GRAMEDICA |