EXPRT REVISION KNEE
FDA 510(k) clearance K140830 · decided 2014-07-11
Clearance details
- K-number
- K140830
- Device name
- EXPRT REVISION KNEE
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-02
- Decision date
- 2014-07-11
- Days to decision
- 100 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 |
|---|---|---|
| Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt recall (Z-0165-2016) | Encore Medical, Lp | 2015-10-26 |