The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Metal-backed Patella.
| Device ID | K932246 |
| 510k Number | K932246 |
| Device Name: | FOUNDATION METAL-BACKED PATELLA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | Webb |
| Correspondent | Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-10 |
| Decision Date | 1994-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912108317 | K932246 | 000 |
| 00888912108300 | K932246 | 000 |
| 00888912108287 | K932246 | 000 |
| 00888912108263 | K932246 | 000 |
| 00888912108256 | K932246 | 000 |