| Primary Device ID | 00190837066390 |
| NIH Device Record Key | 741a1037-ebda-4bd2-bca0-b5174a62b1d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tarsa Link Bunion |
| Version Model Number | 154-135 |
| Catalog Number | 154-135 |
| 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 | 00190837066390 [Primary] |
| HRS | Plate, fixation, bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
Moist Heat or Steam Sterilization
[00190837066390]
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 |
| 00190837066505 | C-Shaped 8mm Trial |
| 00190837066499 | C-Shaped 6mm & 7mm Trial |
| 00190837066482 | C-Shaped 4mm & 5mm Trial |
| 00190837066475 | Tarsa-Link Bunion Installer |
| 00190837066468 | Bunion Spreader |
| 00190837066451 | Implant Installer, Bunion |
| 00190837066444 | Tarsa-Link Bunion Wedge Screw Caddy |
| 00190837066437 | 18mm x 9mm, Tarsa-Link C-Shaped Wedge Implant Caddy |
| 00190837066420 | Straight Drill, 2.3mm |
| 00190837066413 | 2.0mm, Hex Straight Screwdriver |
| 00190837066406 | 20mm Drill |
| 00190837066390 | Adjustable Drill Guide |
| 00190837066383 | Tarsa-Link Bunion Lock Plate |
| 00190837066376 | Tarsa-Link C-Shaped Wedge System Tray, Base |
| 00190837066369 | Tarsa-Link C-Shaped Wedge System Tray, Insert |
| 00190837066352 | Tarsa-Link C-Shaped Wedge System Tray, Lid |
| 00190837066345 | 114-220 |
| 00190837022693 | 18mm x 9mm x 8mm, Tarsa-Link C-Shaped Wedge, Midline |
| 00190837022686 | 18mm x 9mm x 7mm, Tarsa-Link C-Shaped Wedge, Midline |
| 00190837022679 | 18mm x 9mm x 6mm, Tarsa-Link C-Shaped Wedge, Midline |
| 00190837022662 | 18mm x 9mm x 5mm, Tarsa-Link C-Shaped Wedge, Midline |
| 00190837022655 | 18mm x 9mm x 4mm, Tarsa-Link C-Shaped Wedge, Midline |
| 00190837022648 | Variable Angle Screw, 2.7mm x 20mm |
| 00190837022631 | Variable Angle Screw, 2.7mm x 18mm |
| 00190837022624 | Variable Angle Screw, 2.7mm x 16mm |
| 00190837022617 | Variable Angle Screw, 2.7mm x 14mm |
| 00190837022600 | Variable Angle Screw, 2.7mm x 12mm |
| 00190837022594 | Variable Angle Screw, 2.7mm x 10mm |
| 00190837022587 | Variable Angle Screw, 2.7mm x 8mm |
| 00190837022570 | Variable Angle Screw, 2.3mm x 20mm |
| 00190837022563 | Variable Angle Screw, 2.3mm x 18mm |
| 00190837022556 | Variable Angle Screw, 2.3mm x 16mm |
| 00190837022549 | Variable Angle Screw, 2.3mm x 14mm |
| 00190837022532 | Variable Angle Screw, 2.3mm x 12mm |
| 00190837022525 | Variable Angle Screw, 2.3mm x 10mm |
| 00190837022518 | Variable Angle Screw, 2.3mm x 8mm |