The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Plasma Sprayed Metal-backed Patella.
| Device ID | K973672 |
| 510k Number | K973672 |
| Device Name: | FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| 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 | 1997-09-26 |
| Decision Date | 1997-12-18 |
| Summary: | summary |