| Primary Device ID | 00840606187497 |
| NIH Device Record Key | aaee91d0-fe6f-4aa2-a1e4-64593c9dde34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Overwatch |
| Version Model Number | SP-108-260-00 |
| Company DUNS | 610712213 |
| Company Name | SPINAL ELEMENTS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840606187497 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
[00840606187497]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-22 |
| Device Publish Date | 2025-05-14 |
| 00840606154895 | MIS SET SCREW CADDY LID |
| 00840606154888 | MIS SET SCREW CADDY BASE |
| 00840606154871 | MIS SET SCREW CADDY |
| 00840606154864 | 8.5 EXTENDED TAB SCREW CADDY |
| 00840606154857 | 7.5 EXTENDED TAB SCREW CADDY |
| 00840606154840 | 6.5 EXTENDED TAB SCREW CADDY |
| 00840606154833 | 5.5 EXTENDED TAB SCREW CADDY |
| 00840606154826 | OVERWATCH® MIS IMPLANT TRAY INSERT 2 |
| 00840606154819 | OVERWATCH® MIS IMPLANT TRAY INSERT 1 |
| 00840606154802 | OVERWATCH® MIS IMPLANT TRAY LID |
| 00840606154796 | OVERWATCH® MIS IMPLANT TRAY BASE |
| 00840606154789 | OVERWATCH® MIS IMPLANT TRAY |
| 00840606154772 | OVERWATCH® MIS INSTRUMENT TRAY INSERT 2 |
| 00840606154765 | OVERWATCH® MIS INSTRUMENT TRAY INSERT 1 |
| 00840606154758 | OVERWATCH® MIS INSTRUMENT TRAY 2 LID |
| 00840606154741 | OVERWATCH® MIS INSTRUMENT TRAY 2 BASE |
| 00840606154734 | OVERWATCH® MIS INSTRUMENT TRAY 2 |
| 00840606154727 | OVERWATCH® MIS INSTRUMENT TRAY 1 INSERT 2 |
| 00840606154710 | OVERWATCH® MIS INSTRUMENT TRAY 1 INSERT 1 |
| 00840606154703 | OVERWATCH® MIS INSTRUMENT TRAY I LID |
| 00840606154697 | OVERWATCH® MISINSTRUMENT TRAY I BASE |
| 00840606154680 | OVERWATCH® MIS INSTRUMENT TRAY I |
| 00840606157223 | 1.4MM X 28IN NITINOL K-WIRE THREADED TROCAR TIP |
| 00840606157216 | 1.4MM X 26IN NITINOL K-WIRE THREADED TROCAR TIP |
| 00840606157209 | 1.4MM X 24IN NITINOL K-WIRE THREADED TROCAR TIP |
| 00840606157193 | 1.4MM X 18IN NITINOL K-WIRE THREADED TROCAR TIP |
| 00840606157186 | 1.4MM X 28IN NITINOL K-WIRE TROCAR TIP |
| 00840606157179 | 1.4MM X 26IN NITINOL K-WIRE TROCAR TIP |
| 00840606157162 | 1.4MM X 24IN NITINOL K-WIRE TROCAR TIP |
| 00840606157155 | 1.4MM X 18IN NITINOL K-WIRE TROCAR TIP |
| 00840606157148 | 1.4MM X 28IN NITINOL K-WIRE THREADED BLUNT TIP |
| 00840606157131 | 1.4MM X 26IN NITINOL K-WIRE THREADED BLUNT TIP |
| 00840606157124 | 1.4MM X 24IN NITINOL K-WIRE THREADED BLUNT TIP |
| 00840606157117 | 1.4MM X 18IN NITINOL K-WIRE THREADED BLUNT TIP |
| 00840606157100 | 1.4MM X 28IN NITINOL K-WIRE BLUNT TIP |
| 00840606157094 | 1.4MM X 26IN NITINOL K-WIRE BLUNT TIP |
| 00840606157087 | 1.4MM X 24IN NITINOL K-WIRE BLUNT TIP |
| 00840606157070 | 1.4MM X 18IN NITINOL K-WIRE BLUNT TIP |
| 00840606155366 | OVERWATCH® ROD-TO-ROD CONNECTOR CADDY LID |
| 00840606155359 | OVERWATCH® ROD-TO-ROD CONNECTOR CADDY BASE |
| 00840606155342 | OVERWATCH® ROD-TO-ROD CONNECTOR CADDY |
| 00840606155335 | OVERWATCH® OFFSET CONNECTOR CADDY LID |
| 00840606155328 | OVERWATCH® OFFSET CONNECTOR CADDY BASE |
| 00840606155311 | OVERWATCH® OFFSET CONNECTOR CADDY |
| 00840606155304 | OVERWATCH® ILIAC SCREW CADDY 2 LID |
| 00840606155298 | OVERWATCH® ILIAC SCREW CADDY 2 BASE |
| 00840606155281 | OVERWATCH® ILIAC SCREW CADDY 2 |
| 00840606155274 | OVERWATCH® ILIAC SCREW CADDY 1 LID |
| 00840606155267 | OVERWATCH® ILIAC SCREW CADDY 1 BASE |
| 00840606155250 | OVERWATCH® ILIAC SCREW CADDY 1 |