The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Caas Unicomparmental Knee System.
| Device ID | K900619 |
| 510k Number | K900619 |
| Device Name: | CAAS UNICOMPARMENTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
| Contact | Gregory C Rose |
| Correspondent | Gregory C Rose TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
| 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 | 1990-02-08 |
| Decision Date | 1990-06-11 |