Porous Patella
FDA 510(k) clearance K212941 · decided 2022-01-20
Clearance details
- K-number
- K212941
- Device name
- Porous Patella
- Applicant
- Encore Medical, L.P. Dba Djo Surgical
- Decision
- Substantially Equivalent
- Date received
- 2021-09-15
- Decision date
- 2022-01-20
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- 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 |
|---|---|---|
| EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 80 recall (Z-1384-2023) | Encore Medical, LP | 2023-04-12 |