| Primary Device ID | 03663136023274 |
| NIH Device Record Key | 96099d87-e7e6-42f7-ab1b-7261d42474ba |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | C1-A211 |
| Company DUNS | 390377518 |
| Company Name | SPINEVISION |
| 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 | 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 |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03663136023274 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[03663136023274]
Moist Heat or Steam Sterilization
[03663136023274]
Moist Heat or Steam Sterilization
[03663136023274]
Moist Heat or Steam Sterilization
[03663136023274]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-12-19 |
| Device Publish Date | 2016-02-07 |
| 03663136032030 - Hexanium® TLIF | 2025-01-06 Cage Holder |
| 03663136032047 - Hexanium® TLIF | 2025-01-06 Cage Holder Handle |
| 03663136032276 - Hexanium® TLIF | 2025-01-06 Curettes Tray |
| 03663136013619 - P.L.U.S.® | 2024-12-27 Clip guide long stroke |
| 03663136013626 - P.L.U.S.® | 2024-12-27 Clip introducer long stroke |
| 03663136001746 - C3® ACPS | 2024-12-20 4.0 mm x 12 mm dual purpose screw |
| 03663136001906 - C3® ACPS | 2024-12-20 31.5 mm plate with SLS |
| 03663136002415 - C3® ACPS | 2024-12-20 4.0 mm x 20 mm variable angle screw |