| Primary Device ID | 10889981100629 |
| NIH Device Record Key | d5eb87d5-c140-45a7-bf57-299cf07dd696 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Facet Fixation |
| Version Model Number | 95-8101 |
| Catalog Number | 95-8101 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| 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 | true |
| 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(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981100629 [Primary] |
| OJH | Orthopedic tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
[10889981100629]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-08 |
| Device Publish Date | 2016-02-04 |
| 10889981143183 | Facet Lag Screw, 4.5mm x 54mm |
| 10889981143176 | Facet Screw, 4.5mm x 54mm |
| 10889981122836 | Facet Lag Screw 4.5MM x 58MM |
| 10889981100674 | Washer Caddy |
| 10889981100667 | 4.5mm Lag Screw Caddy |
| 10889981100650 | 4.5mm Screw Caddy |
| 10889981100643 | Facet Tray Lid |
| 10889981100636 | Facet Tray Insert |
| 10889981100629 | Facet Tray Base |
| 10889981100612 | Facet Tray |
| 10889981100605 | Dilator Handle |
| 10889981100599 | Retrieval Tool |
| 10889981100582 | Large Dilator |
| 10889981100575 | Medium Dilator |
| 10889981100568 | Small Dilator |
| 10889981100551 | Drill Guide |
| 10889981100544 | 5.0mm Cannulated Tap |
| 10889981100537 | 4.5mm Cannulated Tap |
| 10889981100520 | Access Needle Stylet |
| 10889981100513 | Slim T Handle |
| 10889981100506 | Ratcheting Pineapple Handle Push Forward |
| 10889981100490 | Facet Access Needle |
| 10889981100483 | Facet Universal Driver Shaft |
| 10889981100476 | Facet Universal Driver Handle |
| 10889981100469 | Washer Retaining Sheath |
| 10889981100452 | Drill for DIA 5.0mm Facet Screw |
| 10889981100445 | Drill for DIA 4.5mm Facet Screw |
| 10889981100438 | 3.5mm Cannulated Driver |
| 10889981100421 | Guidewire, 25 in |
| 10889981077037 | Facet Lag Screw 4.5MM x 55MM |
| 10889981077020 | Facet Lag Screw 4.5MM x 50MM |
| 10889981077006 | Facet Lag Screw 4.5MM x 46MM |
| 10889981076979 | Facet Lag Screw 4.5MM x 42MM |
| 10889981076955 | Facet Lag Screw 4.5MM x 38MM |
| 10889981076931 | Facet Lag Screw 4.5MM x 34MM |
| 10889981076917 | Facet Lag Screw 4.5MM x 30MM |
| 10889981076894 | Facet Lag Screw 4.5MM x 26MM |
| 10889981076641 | Facet Screw 4.5MM x 55MM |
| 10889981076634 | Facet Screw 4.5MM x 50MM |
| 10889981076610 | Facet Screw 4.5MM x 46MM |
| 10889981076597 | Facet Screw 4.5MM x 42MM |
| 10889981076573 | Facet Screw 4.5MM x 38MM |
| 10889981076559 | Facet Screw 4.5MM x 34MM |
| 10889981076535 | Facet Screw 4.5MM x 30MM |
| 10889981076511 | Facet Screw 4.5MM x 26MM |
| 10889981076467 | Facet Washer |