The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Continuum Knee System (cks)-modification.
| Device ID | K903286 |
| 510k Number | K903286 |
| Device Name: | CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| Contact | Dave Martinez |
| Correspondent | Dave Martinez TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| 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 | 1990-07-16 |
| Decision Date | 1990-10-12 |