EMPOWR Universal Tibial Baseplate
FDA 510(k) clearance K173723 · decided 2018-03-05
Clearance details
- K-number
- K173723
- Device name
- EMPOWR Universal Tibial Baseplate
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2017-12-05
- Decision date
- 2018-03-05
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JWH
- 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 |
|---|---|---|
| DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 recall (Z-2603-2023) | Encore Medical, LP | 2023-09-19 |