The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Addition To The Continuum Knee System (cks(tm)).
| Device ID | K896542 |
| 510k Number | K896542 |
| Device Name: | ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM)) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
| Contact | Dave Martinez |
| Correspondent | Dave Martinez TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-17 |
| Decision Date | 1990-02-15 |