CinchLock Flex Knotless Suture Anchor
FDA 510(k) clearance K151314 · decided 2015-07-23
Clearance details
- K-number
- K151314
- Device name
- CinchLock Flex Knotless Suture Anchor
- Applicant
- Pivot Medical
- Decision
- Substantially Equivalent
- Date received
- 2015-05-18
- Decision date
- 2015-07-23
- Days to decision
- 66 days
- Clearance type
- Special
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, recall (Z-1328-2025) | Stryker Corporation | 2025-03-12 |