510(k) K151314 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
CinchLock Flex Knotless Suture Anchor
| Applicant | Pivot Medical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 23, 2015 |
| Received | May 18, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151314
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2025 | Stryker Corporation Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197 Open, Classified |
MBI | None listed |
| Apr 12, 2016 | Stryker Corporation CinchLock Flex Knotless Anchor with Inserter;
Model number CAT02643;
Orthopedic:
The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradab Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.