FDA 510(k), K230857, TiLink-P SI Joint Fusion System
FDA 510(k), K230857, TiLink-P SI Joint Fusion System
| 510(k) Number | K230857 |
| Device Classification Name | Sacroiliac Joint Fixation |
| Device Name | TiLink-P SI Joint Fusion System |
| Applicant | SurGenTec, LLC 911 Clint Moore Rd. Boca Raton, FL 33487 |
| Regulation Number | 888.304 |
| Classification Product Code | OUR |
| Date Received | 03/29/2023 |
| Decision Date | 09/25/2023 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Orthopedic |
| 510k Review Panel | Orthopedic |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 1017 |
| Redacted Pages | 654 |
| Unredacted Pages | 363 |
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