HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA
FDA 510(k) clearance K113756 · decided 2012-03-14
Clearance details
- K-number
- K113756
- Device name
- HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-21
- Decision date
- 2012-03-14
- Days to decision
- 84 days
- Clearance type
- Special
- Product code
- OIY
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 recall (Z-0626-2024) | Encore Medical, LP | 2024-01-02 |