FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
FDA 510(k) clearance K970031 · decided 1997-04-02
Clearance details
- K-number
- K970031
- Device name
- FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
- Applicant
- Encore Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-03
- Decision date
- 1997-04-02
- Days to decision
- 89 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 |
|---|---|---|
| Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction recall (Z-0349-2012) | Encore Medical, Lp | 2011-12-02 |
| FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distr recall (Z-2466-2008) | Encore Medical, Lp | 2008-09-29 |