The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Uni Knee.
| Device ID | K022437 |
| 510k Number | K022437 |
| Device Name: | UNI KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Joanna Droege |
| Correspondent | Joanna Droege ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-25 |
| Decision Date | 2002-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912113342 | K022437 | 000 |
| 00888912113311 | K022437 | 000 |
| 00888912113328 | K022437 | 000 |
| 00888912113335 | K022437 | 000 |
| 00888912113359 | K022437 | 000 |
| 00888912113366 | K022437 | 000 |
| 00888912113373 | K022437 | 000 |
| 00888912113380 | K022437 | 000 |
| 00888912113281 | K022437 | 000 |
| 00888912113298 | K022437 | 000 |