The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Continuum Knee System (cks).
| Device ID | K914072 |
| 510k Number | K914072 |
| Device Name: | CONTINUUM KNEE SYSTEM (CKS) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| Contact | Richard W Cudworth |
| Correspondent | Richard W Cudworth TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-11 |
| Decision Date | 1992-02-18 |