| Primary Device ID | 00190837063757 |
| NIH Device Record Key | af7d9acb-8788-4f9f-a48f-affbb1a3481b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tarsa-Link Wedge Fixation System |
| Version Model Number | 154-311 |
| Catalog Number | 154-311 |
| Company DUNS | 183641617 |
| Company Name | Life Spine, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190837063757 [Primary] |
| HRS | Plate, fixation, bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
[00190837063757]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-15 |
| Device Publish Date | 2019-11-07 |
| 00190837015565 | 27-2219-712 |
| 00190837015558 | 27-2219-711 |
| 00190837015541 | 27-2219-710 |
| 00190837015534 | 27-2219-709 |
| 00190837015527 | 27-1613-712 |
| 00190837015510 | 27-1613-711 |
| 00190837015503 | 27-1613-710 |
| 00190837015497 | 27-1613-709 |
| 00190837015480 | 26-2219-708 |
| 00190837015473 | 26-2219-707 |
| 00190837015466 | 26-2219-706 |
| 00190837015459 | 26-2219-705 |
| 00190837015442 | 26-1613-708 |
| 00190837015435 | 26-1613-707 |
| 00190837015428 | 26-1613-706 |
| 00190837015411 | 26-1613-705 |
| 00190837015404 | 154-2-020 |
| 00190837015398 | 154-2-018 |
| 00190837015381 | 154-2-016 |
| 00190837015374 | 154-2-014 |
| 00190837015367 | 154-2-012 |
| 00190837015350 | 154-2-010 |
| 00190837015343 | 154-1-020 |
| 00190837015336 | 154-1-018 |
| 00190837015329 | 154-1-016 |
| 00190837015312 | 154-1-014 |
| 00190837015305 | 154-1-012 |
| 00190837015299 | 154-1-010 |
| 00190837063788 | Tarsa-Link Dual Barrel Guide/Inserter, Size 9-12 |
| 00190837063771 | Tarsa-Link Dual Barrel Guide/Inserter, Size 5-8 |
| 00190837063764 | 22mm x 19mm x 11mm/12mm Trial |
| 00190837063757 | 22mm x 19mm x 9mm/10mm Trial |
| 00190837063740 | 22mm x 19mm x 7mm/8mm Trial |
| 00190837063733 | 22mm x 19mm x 5mm/6mm Trial |
| 00190837063726 | 16mm x 13mm x 11mm/12mm Trial |
| 00190837063719 | 16mm x 13mm x 9mm/10mm Trial |
| 00190837063702 | 16mm x 13mm x 7mm/8mm Trial |
| 00190837063696 | 16mm x 13mm x 5mm/6mm Trial |
| 00190837063689 | Tarsa-Link Installer 16mm x 13mm |
| 00190837063672 | Tarsa-Link Installer 22mm x 19mm |
| 00190837063665 | Tarsa-Link 16x13 Installer |
| 00190837063658 | Tarsa-Link 22x19 Installer |
| 00190837063641 | Tarsa-Link Fixation Pin |
| 00190837063634 | Tarsa-Link 20mm Drill |
| 00190837063627 | Tarsa-Link Adjustable Drill Guide |
| 00190837063610 | Tarsa-Link Bunion Fixation Pin |
| 00190837063603 | Guide Pin Spreader |
| 00190837063597 | Bone Spreader, Smooth |
| 00190837063580 | Tarsa-Link Ti Stand-Alone Wedge Fixation System |
| 00190837063573 | Tarsa-Link Sterilization Tray Bottom |