| Primary Device ID | 00190837066338 |
| NIH Device Record Key | 21e913dd-06d6-424b-a3b8-21ecb20471eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ti Pro-Link Stand-Alone Cervical System |
| Version Model Number | 129-396 |
| Catalog Number | 129-396 |
| 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 | 00190837066338 [Primary] |
| OVE | Intervertebral fusion device with integrated fixation, cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837066338]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-11-06 |
| 00190837017729 | 24-1613-12T |
| 00190837017712 | 24-1613-11T |
| 00190837017705 | 24-1613-10T |
| 00190837017699 | 24-1613-09T |
| 00190837017682 | 21-1613-08T |
| 00190837017675 | 21-1613-07T |
| 00190837017668 | 21-1613-06T |
| 00190837017651 | 21-1613-05T |
| 00190837017644 | 23-1613-712T |
| 00190837017637 | 23-1613-711T |
| 00190837017620 | 23-1613-710T |
| 00190837017613 | 23-1613-709T |
| 00190837017606 | 20-1613-708T |
| 00190837017590 | 20-1613-707T |
| 00190837017583 | 20-1613-706T |
| 00190837017576 | 20-1613-705T |
| 00190837066338 | Pro-Link 14 x 11 Implant Caddy |
| 00190837066321 | Pro-Link Screw Driver, Fixed Angle |
| 00190837066314 | Pro-Link Tap 3.0mm, Fixed Angle |
| 00190837066307 | Pro-Link Drill 3.0mm, Fixed Angle |