FOUNDATION METAL-BACKED PATELLA
FDA 510(k) clearance K932246 · decided 1994-07-22
Clearance details
- K-number
- K932246
- Device name
- FOUNDATION METAL-BACKED PATELLA
- Applicant
- Encore Orthopedics, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1993-05-10
- Decision date
- 1994-07-22
- Days to decision
- 438 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
+ Add to Predicate Builder ◉ Watch Encore Orthopedics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551 recall (Z-1255-2010) | Encore Medical, Lp | 2010-04-07 |