| Primary Device ID | 10705034192727 |
| NIH Device Record Key | 2db9abb0-d1a9-4cbb-b3e8-4bbdbb621733 |
| Commercial Distribution Discontinuation | 2019-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUMMIT |
| Version Model Number | 274610100 |
| Catalog Number | 274610100 |
| Company DUNS | 107105876 |
| Company Name | DEPUY SPINE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034192727 [Primary] |
| HWR | DRIVER, PROSTHESIS |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-12-12 |
| Device Publish Date | 2016-12-31 |
| 10705034193106 | SUMMIT FIXATION SYSTEM ANTI-CROSS THREAD DEVICE |
| 10705034192949 | SUMMIT SI OCT SPINAL FIXATION SYSTEM INSERTER |
| 10705034192932 | SUMMIT SI OCT SPINAL FIXATION SYSTEM PIN NUT INSERTER |
| 10705034192727 | SUMMIT FIXATION SYSTEM HEX DRIVER INSERTER 2.5mm |
| 10705034022901 | SUMMIT SI OCT SPINAL FIXATION SYSTEM DUAL WEDDING BAND ASSEMBLY 3.0/5.5mm |
| 10705034022857 | SUMMIT SI OCT SPINAL FIXATION SYSTEM DUAL DIAMETER ROD 3.0/ 5.5 X 600mm |
| 10705034022789 | SUMMIT SI OCT SPINAL FIXATION SYSTEM 3 HOLE INVERTED Y-PLATE 45mm |
| 10705034022772 | SUMMIT SI OCT SPINAL FIXATION SYSTEM 3 HOLE INVERTED Y-PLATE 37mm |
| 10705034022765 | SUMMIT SI OCT SPINAL FIXATION SYSTEM 3 HOLE INVERTED Y-PLATE 31mm |
| 10705034022758 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL INVERTED Y-PLATE 45mm |
| 10705034022727 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 45mm |
| 10705034022710 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 37mm |
| 10705034022703 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 31mm |
| 10705034022673 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 31mm |
| 10705034022352 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 50mm |
| 10705034022031 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 28mm |
| 10705034021942 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 10mm |
| 10705034021928 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 50mm |
| 10705034021911 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 48mm |
| 10705034021713 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 8mm |
| 10705034021706 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 50mm |
| 10705034021638 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 36mm |
| 10705034021621 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 34mm |
| 10705034021607 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 30mm |
| 10705034021591 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 28mm |
| 10705034021508 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 10mm |
| 10705034021119 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 50mm |
| 10705034021102 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 48mm |
| 10705034021096 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 46mm |
| 10705034021089 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 44mm |
| 10705034021072 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 42mm |
| 10705034020679 | SUMMIT BONE SCREWS BONE SCREW 3.5 x 10mm |
| 10705034192666 | SUMMIT FIXATION SYSTEM DRILL 2mm |
| 10705034193564 | SUMMIT SI OCT SPINAL FIXATION SYSTEM DEPTH GAUGE 6-50mm Plus or Minus 15 Percent |
| 10705034193557 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL BONE SCREW GAUGE |
| 10705034193540 | SUMMIT SI OCT SPINAL FIXATION SYSTEM FIXED DEPTH GUIDE 14/16mm |
| 10705034193533 | SUMMIT SI OCT SPINAL FIXATION SYSTEM FIXED DEPTH GUIDE 10/12mm |
| 10705034193526 | SUMMIT SI OCT SPINAL FIXATION SYSTEM FIXED DEPTH GUIDE 6/8mm |
| 10705034193496 | SUMMIT SI OCT SPINAL FIXATION SYSTEM TEMPLATE, DUAL DIAMETER ROD 420mm |
| 10705034193489 | SUMMIT SI OCT SPINAL FIXATION SYSTEM TEMPLATE, TRANSITION ROD 3/4/3mm |
| 10705034193465 | SUMMIT SI OCT SPINAL FIXATION SYSTEM X20 HEXLOBE DRIVER ASSEMBLY |
| 10705034193458 | SUMMIT SI OCT SPINAL FIXATION SYSTEM HEX DRIVER SHAFT 2.0mm |
| 10705034193441 | SUMMIT OCT SPINAL FIXATION SYSTEM TORQUE LIMITING DRIVER |
| 10705034193427 | SUMMIT OCT SPINAL FIXATION SYSTEM TEMPLATE, INVERTED-Y PLATE 37mm |
| 10705034193410 | SUMMIT OCT SPINAL FIXATION SYSTEM TEMPLATE, INVERTED-Y PLATE 31mm |
| 10705034193373 | SUMMIT SI OCT SPINAL FIXATION SYSTEM T-PLATE TEMPLATE 45mm |
| 10705034193366 | SUMMIT SI OCT SPINAL FIXATION SYSTEM T-PLATE TEMPLATE 37mm |
| 10705034193304 | SUMMIT SI OCT SPINAL FIXATION SYSTEM INSERTION SOCKET WRENCH |
| 10705034193298 | SUMMIT SI OCT SPINAL FIXATION SYSTEM NUT DRIVER |
| 10705034193274 | SUMMIT SI OCT SPINAL FIXATION SYSTEM HEX DRIVER, MINIMAL ACCESS 2.5mm |