| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10889981069315 | 41-8055-1 | 41-8055-1 | Solid Screw 8.00 x 55mm | MNI,NKB,KWQ,MNH | ORTHOSIS, SPINAL PEDICLE FIXATION,Orthosis, spinal pedicle fixation, for degener ORTHOSIS, SPINAL PEDICLE FIXATION,Orthosis, spinal pedicle fixation, for degenerative disc disease,APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,Orthosis, spondylolisthesis spinal fixation | 2 | Mariner |
| 2 | 10889981157302 | SR-0223-22 | SR-0223-22 | Cambria Trial without Depth Stop | HWT | TEMPLATE | 1 | Specials |
| 3 | 10889981068042 | 41-6085-2 | 41-6085-2 | Cannulated Screw 6.00 x 85mm | NKB,MNI,KWQ,MNH | Orthosis, spinal pedicle fixation, for degenerative disc disease,ORTHOSIS, SPINA Orthosis, spinal pedicle fixation, for degenerative disc disease,ORTHOSIS, SPINAL PEDICLE FIXATION,APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,Orthosis, spondylolisthesis spinal fixation | 2 | Mariner |
| 4 | 10889981067960 | 41-6065-2 | 41-6065-2 | Cannulated Screw 6.00 x 65mm | MNH,NKB,MNI,KWQ | Orthosis, spondylolisthesis spinal fixation,Orthosis, spinal pedicle fixation, f Orthosis, spondylolisthesis spinal fixation,Orthosis, spinal pedicle fixation, for degenerative disc disease,ORTHOSIS, SPINAL PEDICLE FIXATION,APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | 2 | Mariner |
| 5 | 10889981067892 | 41-6050-1 | 41-6050-1 | Solid Screw 6.00 x 50mm | KWQ,MNH,NKB,MNI | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,Orthosis, spondylolisthesis spin APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,Orthosis, spondylolisthesis spinal fixation,Orthosis, spinal pedicle fixation, for degenerative disc disease,ORTHOSIS, SPINAL PEDICLE FIXATION | 2 | Mariner |
| 6 | 10889981067885 | 41-6045-2 | 41-6045-2 | Cannulated Screw 6.00 x 45mm | MNI,MNH,NKB,KWQ | ORTHOSIS, SPINAL PEDICLE FIXATION,Orthosis, spondylolisthesis spinal fixation,Or ORTHOSIS, SPINAL PEDICLE FIXATION,Orthosis, spondylolisthesis spinal fixation,Orthosis, spinal pedicle fixation, for degenerative disc disease,APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | 2 | Mariner |
| 7 | 10889981285814 | 86-1107 | 86-1107 | Trial 16x12x7mm, 7 Deg Lordosis, w/ Depth Stop | HWT | TEMPLATE | 1 | Shoreline ACS |
| 8 | 10889981272678 | SR-0589 | SR-0589 | Outrigger Compressor | HWN | INSTRUMENT, COMPRESSION | 1 | Specials |
| 9 | 10889981273446 | SR-0654 | SR-0654 | Driver Sleeve | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Specials |
| 10 | 10889981269395 | SR-0632 | SR-0632 | Tab Remover | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Specials |
| 11 | 10889981257347 | SR-0575 | SR-0575 | Pedicle Marker | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Specials |
| 12 | 10889981247683 | AP2-990004 | AP2-990004 | Streamline Handle, Orange, Spin Top | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Admiral |
| 13 | 10889981217143 | RA3-009003 | RA3-009003 | Inline Anchor & Screw Caddy | MAX,OVD | Intervertebral fusion device with bone graft, lumbar,Intervertebral fusion devic Intervertebral fusion device with bone graft, lumbar,Intervertebral fusion device with integrated fixation, lumbar | 2 | Meridian |
| 14 | 10889981213022 | TA2-006000 | TA2-006000 | Graft Block | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Reef TA |
| 15 | 10889981212483 | MM2-100270 | MM2-100270 | MIS Rod Inserter | OLO,KWQ,NKB | Orthopedic stereotaxic instrument,Appliance, fixation, spinal intervertebral bod Orthopedic stereotaxic instrument,Appliance, fixation, spinal intervertebral body,Thoracolumbosacral pedicle screw system | 2 | Mariner MIS |
| 16 | 10889981206369 | TO2-928074 | TO2-928074 | Trial, 9mm x 28mm x 7mm, 5 Deg | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Reef TO |
| 17 | 10889981195885 | MC3-900020 | MC3-900020 | Mariner Midline Shank Caddy | OJH | Orthopedic tray | 1 | Mariner MCT |
| 18 | 10889981178567 | 91-9617 | 91-9617 | NewPort MIS Rod Caddy | OJH | Orthopedic tray | 1 | NewPort™ |
| 19 | 10889981176396 | SR-0328-30 | SR-0328-30 | Open Body | HXW | BENDER | 1 | Specials |
| 20 | 10889981174774 | SR-0405 | SR-0405 | 90 DEG Curette | HTF | CURETTE | 1 | Specials |
| 21 | 10889981171957 | SR-0130-01 | SR-0130-01 | Short 3mm DLTA Driver, A/O | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Specials |
| 22 | 10889981115357 | 26-07-0372 | 26-07-0372 | 72mm | KWQ | Appliance, fixation, spinal intervertebral body | 2 | Cordant |
| 23 | 10889981115326 | 26-07-0363 | 26-07-0363 | 63mm | KWQ | Appliance, fixation, spinal intervertebral body | 2 | Cordant |
| 24 | 10889981097332 | 95-5716 | 95-5716 | Mask, 16mm | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Zuma |
| 25 | 10889981097325 | 95-5714 | 95-5714 | Mask, 14mm | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Zuma |
| 26 | 10889981160067 | 33-40-0142 | 33-40-0142 | Graft Block | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Vu aPOD™ Prime NanoMetalene® |
| 27 | 10889987170695 | MC2-004090 | MC2-004090 | Rod Holder | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Mariner MCT |
| 28 | 10889987170305 | MC2-004110 | MC2-004110 | Counter Torque, Slim | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
| 29 | 10889987170299 | MC2-004100 | MC2-004100 | Compressor, Slim | HWN | INSTRUMENT, COMPRESSION | 1 | Mariner MCT |
| 30 | 10889987170282 | MC2-004080 | MC2-004080 | Rod Measurement Wand | HTJ | GAUGE, DEPTH | 1 | Mariner MCT |
| 31 | 10889987170275 | MC2-004052 | MC2-004052 | Slim Head Inserter, Long | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
| 32 | 10889987170268 | MC2-004051 | MC2-004051 | Slim Head Inserter, Short | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
| 33 | 10889987170244 | MC2-004013 | MC2-004013 | Face-cutting Reamer, T-Handle | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Mariner MCT |
| 34 | 10889987170237 | MC2-004012 | MC2-004012 | Face-cutting Reamer, Tri-flat | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Mariner MCT |
| 35 | 10889987170220 | MC2-004011 | MC2-004011 | Face-cutting Reamer, A/O | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Mariner MCT |
| 36 | 10889987170213 | MC2-004010 | MC2-004010 | Face-cutting Reamer, 1/4"Quick-connect | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Mariner MCT |
| 37 | 10889987170206 | MC2-003042 | MC2-003042 | 4.0mm Drill, Solid, Tri-Flat | HTW | BIT, DRILL | 1 | Mariner MCT |
| 38 | 10889987170190 | MC2-003041 | MC2-003041 | 4.0mm Drill, Solid, A/O QC | HTW | BIT, DRILL | 1 | Mariner MCT |
| 39 | 10889987170183 | MC2-003040 | MC2-003040 | 4.0mm Drill, Solid, 1/4" QC | HTW | BIT, DRILL | 1 | Mariner MCT |
| 40 | 10889987170176 | MC2-003037 | MC2-003037 | 3.5mm Drill, Solid, Tri-Flat | HTW | BIT, DRILL | 1 | Mariner MCT |
| 41 | 10889987170169 | MC2-003036 | MC2-003036 | 3.5mm Drill, Solid, A/O QC | HTW | BIT, DRILL | 1 | Mariner MCT |
| 42 | 10889987170152 | MC2-003035 | MC2-003035 | 3.5mm Drill, Solid, 1/4" QC | HTW | BIT, DRILL | 1 | Mariner MCT |
| 43 | 10889987170145 | MC2-003032 | MC2-003032 | 3.0mm Drill, Solid, Tri-Flat | HTW | BIT, DRILL | 1 | Mariner MCT |
| 44 | 10889987170138 | MC2-003031 | MC2-003031 | 3.0mm Drill, Solid, A/O QC | HTW | BIT, DRILL | 1 | Mariner MCT |
| 45 | 10889987170121 | MC2-003030 | MC2-003030 | 3.0mm Drill, Solid, 1/4" QC | HTW | BIT, DRILL | 1 | Mariner MCT |
| 46 | 10889987170114 | MC2-003012 | MC2-003012 | Cortical Screw Shank Driver, Long | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
| 47 | 10889987170107 | MC2-003011 | MC2-003011 | Cortical Screw Shank Driver, Short | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
| 48 | 10889987170091 | MC2-003010 | MC2-003010 | Cortical Screw Shank Driver | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
| 49 | 10889987170084 | MC2-002065 | MC2-002065 | 6.5mm Tap, Cortical, Cannulated | HWX | TAP, BONE | 1 | Mariner MCT |
| 50 | 10889987170077 | MC2-002060 | MC2-002060 | 6.0mm Tap, Cortical, Cannulated | HWX | TAP, BONE | 1 | Mariner MCT |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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 | |
| 2 | 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 |
| 3 | 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 |
| 4 | 07350055430066 | A0210-11 | A0210-11 | CERAMENT™BONE VOID FILLER | BONE SUPPORT AB | |
| 5 | 07350055430042 | A0210-09 | A0210-09 | CERAMENT™BONE VOID FILLER | BONE SUPPORT AB | |
| 6 | 07350055430035 | A0210-08 | A0210-08 | CERAMENT™BONE VOID FILLER | BONE SUPPORT AB | |
| 7 | 06953122702304 | Gr-3 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 8 | 06953122702298 | Gr-2 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 9 | 06953122702281 | Gr-1 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 10 | 06953122702274 | Re-7 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 11 | 06953122702267 | Re-6 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 12 | 06953122702250 | Re-5 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 13 | 06953122702243 | Re-4 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 14 | 06953122702236 | Re-3 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 15 | 06953122702212 | Re-2 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 16 | 06953122702205 | Re-1 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 17 | 06953122702199 | Co-5 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 18 | 06953122702182 | Co-4 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 19 | 06953122702175 | Co-3 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 20 | 06953122702168 | Co-2 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 21 | 06953122702151 | Co-1 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 22 | 06438408009730 | 1 | SGN-1500 | Morsels 1.5 cc / 1.5 ml | Ventris SIgnal™ | INION OY |
| 23 | 06438408009617 | 1 | BRS-1602 | Block 5 x 10 x 4 mm | Inion OTPS BioRestore™ | INION OY |
| 24 | 06438408009587 | 1 | BRS-5497 | Block, Large, Wedge 14 mm | Inion BioRestore™ Sahara | INION OY |
| 25 | 06438408009570 | 1 | BRS-5496 | Block, Large, Wedge 12 mm | Inion BioRestore™ Sahara | INION OY |
| 26 | 06438408009563 | 1 | BRS-5495 | Block, Large, Wedge 10 mm | Inion BioRestore™ Sahara | INION OY |
| 27 | 06438408009556 | 1 | BRS-5494 | Block, Large, Wedge 8 mm | Inion BioRestore™ Sahara | INION OY |
| 28 | 06438408009549 | 1 | BRS-5493 | Block, Large 14 mm | Inion BioRestore™ Sahara | INION OY |
| 29 | 06438408009532 | 1 | BRS-5492 | Block, Large 12 mm | Inion BioRestore™ Sahara | INION OY |
| 30 | 06438408009525 | 1 | BRS-5491 | Block, Large 10 mm | Inion BioRestore™ Sahara | INION OY |
| 31 | 06438408009518 | 1 | BRS-5490 | Block, Large 8 mm | Inion BioRestore™ Sahara | INION OY |
| 32 | 06438408009501 | 1 | BRS-5487 | Block, Standard, Wedge 14 mm | Inion BioRestore™ Sahara | INION OY |
| 33 | 06438408009495 | 1 | BRS-5486 | Block, Standard, Wedge 12 mm | Inion BioRestore™ Sahara | INION OY |
| 34 | 06438408009488 | 1 | BRS-5485 | Block, Standard, Wedge 10 mm | Inion BioRestore™ Sahara | INION OY |
| 35 | 06438408009471 | 1 | BRS-5484 | Block, Standard, Wedge 8 mm | Inion BioRestore™ Sahara | INION OY |
| 36 | 06438408009464 | 1 | BRS-5483 | Block, Standard 14 mm | Inion BioRestore™ Sahara | INION OY |
| 37 | 06438408009419 | 1 | BRS-5473 | Oval, Standard 7 mm | Inion BioRestore™ Sahara | INION OY |
| 38 | 06438408009402 | 1 | BRS-5472 | Oval, Standard 6 mm | Inion BioRestore™ Sahara | INION OY |
| 39 | 06438408009396 | 1 | BRS-5471 | Oval, Standard 5 mm | Inion BioRestore™ Sahara | INION OY |
| 40 | 06438408009389 | 1 | BRS-5470 | Oval, Standard 4 mm | Inion BioRestore™ Sahara | INION OY |
| 41 | 06438408009372 | 1 | BRS-5464 | Oval, Small 8 mm | Inion BioRestore™ Sahara | INION OY |
| 42 | 06438408009365 | 1 | BRS-5463 | Oval, Small 7 mm | Inion BioRestore™ Sahara | INION OY |
| 43 | 06438408009358 | 1 | BRS-5462 | Oval, Small 6 mm | Inion BioRestore™ Sahara | INION OY |
| 44 | 06438408009341 | 1 | BRS-5461 | Oval, Small 5 mm | Inion BioRestore™ Sahara | INION OY |
| 45 | 06438408009327 | 1 | BRS-5450 | Cylinder 8 x 15 mm | Inion BioRestore™ | INION OY |
| 46 | 06438408009310 | 1 | BRS-5443 | Block 60 x 40 x 8 mm | Inion BioRestore™ | INION OY |
| 47 | 06438408009303 | 1 | BRS-5442 | Block 30 x 20 x 8 mm | Inion BioRestore™ | INION OY |
| 48 | 06438408009297 | 1 | BRS-5441 | Block 15 x 25 x 4 mm | Inion BioRestore™ | INION OY |
| 49 | 06438408009280 | 1 | BRS-5440 | Block 5 x 10 x 4 mm | Inion BioRestore™ | INION OY |
| 50 | 06438408009273 | 1 | BRS-5429 | Block, Wedge 13 mm | Inion BioRestore™ | INION OY |