The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Cks Porous Coated Femoral Component.
| Device ID | K933935 |
| 510k Number | K933935 |
| Device Name: | CKS POROUS COATED FEMORAL COMPONENT |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | TECHMEDICA, INC. 3720 CALLE TECATE Camarillo, CA 93012 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-11 |
| Decision Date | 1994-10-11 |