Stryker All-PEEK Knotless Anchor System
FDA 510(k) clearance K181083 · decided 2018-07-23
Clearance details
- K-number
- K181083
- Device name
- Stryker All-PEEK Knotless Anchor System
- Applicant
- Stryker
- Decision
- Substantially Equivalent
- Date received
- 2018-04-24
- Decision date
- 2018-07-23
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI recall (Z-1147-2020) | Stryker Corporation | 2020-03-02 |
| Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 076133 recall (Z-1148-2020) | Stryker Corporation | 2020-03-02 |