The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Unicompartmental Knee System.
| Device ID | K896648 |
| 510k Number | K896648 |
| Device Name: | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
| Contact | Martha C Miller |
| Correspondent | Martha C Miller CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-24 |
| Decision Date | 1990-06-05 |