FOUNDATION MODULAR TIBIAL BASEPLATE
FDA 510(k) clearance K932425 · decided 1994-07-22
Clearance details
- K-number
- K932425
- Device name
- FOUNDATION MODULAR TIBIAL BASEPLATE
- Applicant
- Encore Orthopedics, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1993-05-19
- Decision date
- 1994-07-22
- Days to decision
- 429 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 |
|---|---|---|
| Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left recall (Z-0826-2010) | Encore Medical, Lp | 2010-02-24 |
| Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, su recall (Z-0622-2010) | Encore Medical, Lp | 2010-01-13 |