| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10886982181770 | 294.767 | 294767 | 4.0MM/2.5MM SCHANZ SCREW 18MM THRD/65MM | LXT,KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE,APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | 2 | NA |
| 2 | 10886982195944 | 357.25 | 35725 | SLIDE HAMMER FOR HAMMER GUIDE | FZY | HAMMER, SURGICAL | 1 | NA |
| 3 | 10886982195920 | 357.221 | 357221 | FEMORAL NAIL HAMMER GUIDE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | NA | |
| 4 | 10886982195913 | 357.22 | 35722 | HAMMER GUIDE FOR SLIDE HAMMER | FZY | HAMMER, SURGICAL | NA | |
| 5 | 10886982195906 | 357.181 | 357181 | FEMORAL NAIL DRIVING ADAPTOR | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | NA | |
| 6 | 10886982195883 | 357.133 | 357133 | EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS | HWB | EXTRACTOR | 1 | NA |
| 7 | 10886982195876 | 357.128 | 357128 | 13.0MM/3.2MM TROCAR | FZX | Guide, surgical, instrument | 1 | NA |
| 8 | 10886982195357 | 356.309 | 356309 | 9MM TREPHINE | HWK | TREPHINE | 1 | NA |
| 9 | 10886982195869 | 357.127 | 357127 | 13.0MM PROTECTION SLEEVE | FZX | Guide, surgical, instrument | 1 | NA |
| 10 | 10886982195791 | 357.096 | 357096 | AIMING ARM FOR 6.0MM TI LOCKING SCREWS | FZX | Guide, surgical, instrument | NA | |
| 11 | 10886982195784 | 357.095 | 357095 | CONNECTING SCREW FOR TI DISTAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 12 | 10886982195777 | 357.073 | 357073 | EXTRACTION HOLDING SLEEVE FOR HIP PIN | FZX | Guide, surgical, instrument | 1 | NA |
| 13 | 10886982195753 | 357.055 | 357055 | SCREWDRIVER HEXAGONAL CANNULATED L365MM | HXX | SCREWDRIVER | 1 | NA |
| 14 | 10886982195746 | 357.054 | 357054 | T-HANDLE | HXC | WRENCH | 1 | NA |
| 15 | 10886982195739 | 357.052 | 357052 | TROCHANTERIC FIXATION NAIL SCREW COMPRESSION NUT | HWC,HSB | Screw, fixation, bone,ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | NA | |
| 16 | 10886982195722 | 357.051 | 357051 | COUPLING SCREW | HXC | WRENCH | 1 | NA |
| 17 | 10886982195715 | 357.047 | 357047 | 6.5MM CANNULATED DRILL BIT QC/330MM | HTW | BIT, DRILL | 1 | NA |
| 18 | 10886982195708 | 357.046 | 357046 | FIXATION SLEEVE | HTW,FZX | BIT, DRILL,Guide, surgical, instrument | 1 | NA |
| 19 | 10886982195692 | 357.039 | 357039 | 2.8MM GUIDE WIRE 350MM | JDW,JDS | PIN, FIXATION, THREADED,NAIL, FIXATION, BONE | 2 | NA |
| 20 | 10886982195685 | 356.982 | 356982 | 4.0MM THREE-FLUTED DRILL BIT QC/215MM/80MM CALIB | GFF,HSZ,HWE,GFA | BUR, SURGICAL, GENERAL & PLASTIC SURGERY,Instrument, surgical, orthopedic, pneum BUR, SURGICAL, GENERAL & PLASTIC SURGERY,Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment,INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT,BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | 1 | NA |
| 21 | 10886982195678 | 356.98 | 35698 | 4.0MM THREE-FLUTED DRILL BIT QC/270MM/95MM CALIB | GFF,HWE,GFA,HSZ | BUR, SURGICAL, GENERAL & PLASTIC SURGERY,INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-PO BUR, SURGICAL, GENERAL & PLASTIC SURGERY,INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT,BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL,Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment | 1 | NA |
| 22 | 10886982195654 | 356.972 | 356972 | 3.2MM THREE-FLUTED DRILL BIT QC/215MM/82MM CALIBRATION | HTW | BIT, DRILL | 1 | NA |
| 23 | 10886982195647 | 356.97 | 35697 | 3.2MM THREE-FLUTED DRILL BIT QC/215MM/80MM CALIB | HTW | BIT, DRILL | 1 | NA |
| 24 | 10886982195623 | 356.830 | 356830 | GUIDE WIRE 3.2MM FOR PFNA BLADE | FZX | Guide, surgical, instrument | 1 | NA |
| 25 | 10886982195616 | 356.825 | 356825 | EXTRACTION SCREW FOR PFNA BLADE | HWB | EXTRACTOR | 1 | NA |
| 26 | 10886982195609 | 356.717 | 356717 | GUIDE WIRE 2.8MM LENGTH 460MM WITH HOOK | HWB | EXTRACTOR | 1 | NA |
| 27 | 10886982195517 | 356.544 | 356544 | INSERTION BOLT FOR TI CANNULATED TIBIAL NAIL | FZX | Guide, surgical, instrument | 1 | NA |
| 28 | 10886982195500 | 356.543 | 356543 | EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 29 | 10886982195494 | 356.542 | 356542 | INSERTION BOLT FOR SOLID TIBIAL NAIL | FZX | Guide, surgical, instrument | 1 | NA |
| 30 | 10886982195463 | 356.49 | 35649 | INSERTER-EXTRACTOR FOR TI TIBIAL & HUMERAL NAILS | HWB | EXTRACTOR | 1 | NA |
| 31 | 10886982195456 | 356.350 | 356350 | RATCHET GRIP | HWB | EXTRACTOR | 1 | NA |
| 32 | 10886982195449 | 356.340 | 356340 | DRIVE SHAFT 490MM | HWB | EXTRACTOR | 1 | NA |
| 33 | 10886982195432 | 356.332 | 356332 | EXTRACTOR HEAD F/12MM NAILS | HWB | EXTRACTOR | 1 | NA |
| 34 | 10886982195425 | 356.331 | 356331 | EXTRACTOR HEAD F/11MM NAILS | HWB | EXTRACTOR | 1 | NA |
| 35 | 10886982195418 | 356.330 | 356330 | EXTRACTOR HEAD F/10MM NAILS | HWB | EXTRACTOR | 1 | NA |
| 36 | 10886982195401 | 356.329 | 356329 | EXTRACTOR HEAD F/9MM NAILS | HWB | EXTRACTOR | 1 | NA |
| 37 | 10886982195395 | 356.328 | 356328 | EXTRACTOR HEAD F/8MM NAILS | HWB | EXTRACTOR | 1 | NA |
| 38 | 10886982195388 | 356.312 | 356312 | 12MM TREPHINE | HWK | TREPHINE | 1 | NA |
| 39 | 10886982195371 | 356.311 | 356311 | 11MM TREPHINE | HWK | TREPHINE | 1 | NA |
| 40 | 10886982195364 | 356.310 | 356310 | 10MM TREPHINE | HWK | TREPHINE | 1 | NA |
| 41 | 10886982195234 | 355.89 | 35589 | 6.0MM/5.0MM DRILL SLEEVE | FZX | Guide, surgical, instrument | 1 | NA |
| 42 | 10886982195227 | 355.88 | 35588 | 5.0MM/3.5MM DRILL SLEEVE | FZX | Guide, surgical, instrument | 1 | NA |
| 43 | 10886982195210 | 355.87 | 35587 | 3.5MM TROCAR | FZX | Guide, surgical, instrument | 1 | NA |
| 44 | 10886982195203 | 355.75 | 35575 | 8.0MM TROCAR | FZX | Guide, surgical, instrument | 1 | NA |
| 45 | 10886982195081 | 355.59 | 35559 | LOCKING NUT FOR 17MM-19MM UNIVERSAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 46 | 10886982195074 | 355.58 | 35558 | LOCKING NUT FOR 13MM-16MM UNIVERSAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 47 | 10886982195067 | 355.57 | 35557 | LOCKING NUT FOR 9MM-12MM UNIVERSAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 48 | 10886982195050 | 355.55 | 35555 | THREADED CONICAL BOLT FOR 17MM-19MM UNIV FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 49 | 10886982195043 | 355.54 | 35554 | THREADED CONICAL BOLT FOR 13MM-16MM UNIV FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 50 | 10886982195036 | 355.53 | 35553 | THREADED CONICAL BOLT FOR 9MM-12MM UNIV FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 07613327064797 | 2102-2305 | 2102-2305 | Bone graft substitute | Vitoss BA Injectable | STRYKER ORTHOBIOLOGICS |
| 2 | 07613327064780 | 2102-2302 | 2102-2302 | Bone graft substitute | Vitoss BA Injectable | STRYKER ORTHOBIOLOGICS |
| 3 | 07613327064773 | 2102-2301 | 2102-2301 | Bone graft substitute | Vitoss BA Injectable | STRYKER ORTHOBIOLOGICS |
| 4 | 07613327064292 | 897015 | 897015 | Injectable HA Bone Cement | HydroSet XT | STRYKER CORPORATION |
| 5 | 07613327064285 | 897010 | 897010 | Injectable HA Bone Cement | HydroSet XT | STRYKER CORPORATION |
| 6 | 07613327064278 | 897005 | 897005 | Injectable HA Bone Cement | HydroSet XT | STRYKER CORPORATION |
| 7 | 07613327064261 | 897003 | 897003 | Injectable HA Bone Cement | HydroSet XT | STRYKER CORPORATION |
| 8 | 07610221014095 | 500500 | - | Orthoss® | GEISTLICH PHARMA AG | |
| 9 | 07610221013142 | 500499 | - | Orthoss® | GEISTLICH PHARMA AG | |
| 10 | 07610221013135 | 500498 | - | - | Orthoss® | GEISTLICH PHARMA AG |
| 11 | 07610221013128 | 500497 | - | Orthoss® | GEISTLICH PHARMA AG | |
| 12 | 07610221013111 | 500502 | - | Orthoss® | GEISTLICH PHARMA AG | |
| 13 | 07610221013104 | 500501 | - | Orthoss® | GEISTLICH PHARMA AG | |
| 14 | 07350086550726 | 2.5cc | OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075) | OssDsign Catalyst | OSSDSIGN AB | |
| 15 | 07350086550719 | 5cc | 104050 | OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075) | OssDsign Catalyst | OSSDSIGN AB |
| 16 | 07350086550702 | 10cc | 104100 | OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075) | OssDsign Catalyst | OSSDSIGN AB |
| 17 | 07350055430066 | A0210-11 | A0210-11 | CERAMENT™BONE VOID FILLER | BONE SUPPORT AB | |
| 18 | 07350055430042 | A0210-09 | A0210-09 | CERAMENT™BONE VOID FILLER | BONE SUPPORT AB | |
| 19 | 07350055430035 | A0210-08 | A0210-08 | CERAMENT™BONE VOID FILLER | BONE SUPPORT AB | |
| 20 | 06953122702304 | Gr-3 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 21 | 06953122702298 | Gr-2 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 22 | 06953122702281 | Gr-1 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 23 | 06953122702274 | Re-7 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 24 | 06953122702267 | Re-6 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 25 | 06953122702250 | Re-5 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 26 | 06953122702243 | Re-4 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 27 | 06953122702236 | Re-3 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 28 | 06953122702212 | Re-2 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 29 | 06953122702205 | Re-1 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 30 | 06953122702199 | Co-5 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 31 | 06953122702182 | Co-4 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 32 | 06953122702175 | Co-3 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 33 | 06953122702168 | Co-2 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 34 | 06953122702151 | Co-1 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 35 | 06438408009730 | 1 | SGN-1500 | Morsels 1.5 cc / 1.5 ml | Ventris SIgnal™ | INION OY |
| 36 | 06438408009617 | 1 | BRS-1602 | Block 5 x 10 x 4 mm | Inion OTPS BioRestore™ | INION OY |
| 37 | 06438408009587 | 1 | BRS-5497 | Block, Large, Wedge 14 mm | Inion BioRestore™ Sahara | INION OY |
| 38 | 06438408009570 | 1 | BRS-5496 | Block, Large, Wedge 12 mm | Inion BioRestore™ Sahara | INION OY |
| 39 | 06438408009563 | 1 | BRS-5495 | Block, Large, Wedge 10 mm | Inion BioRestore™ Sahara | INION OY |
| 40 | 06438408009556 | 1 | BRS-5494 | Block, Large, Wedge 8 mm | Inion BioRestore™ Sahara | INION OY |
| 41 | 06438408009549 | 1 | BRS-5493 | Block, Large 14 mm | Inion BioRestore™ Sahara | INION OY |
| 42 | 06438408009532 | 1 | BRS-5492 | Block, Large 12 mm | Inion BioRestore™ Sahara | INION OY |
| 43 | 06438408009525 | 1 | BRS-5491 | Block, Large 10 mm | Inion BioRestore™ Sahara | INION OY |
| 44 | 06438408009518 | 1 | BRS-5490 | Block, Large 8 mm | Inion BioRestore™ Sahara | INION OY |
| 45 | 06438408009501 | 1 | BRS-5487 | Block, Standard, Wedge 14 mm | Inion BioRestore™ Sahara | INION OY |
| 46 | 06438408009495 | 1 | BRS-5486 | Block, Standard, Wedge 12 mm | Inion BioRestore™ Sahara | INION OY |
| 47 | 06438408009488 | 1 | BRS-5485 | Block, Standard, Wedge 10 mm | Inion BioRestore™ Sahara | INION OY |
| 48 | 06438408009471 | 1 | BRS-5484 | Block, Standard, Wedge 8 mm | Inion BioRestore™ Sahara | INION OY |
| 49 | 06438408009464 | 1 | BRS-5483 | Block, Standard 14 mm | Inion BioRestore™ Sahara | INION OY |
| 50 | 06438408009419 | 1 | BRS-5473 | Oval, Standard 7 mm | Inion BioRestore™ Sahara | INION OY |