The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Techmedica Cad/cam Custom Hip.
| Device ID | K911058 |
| 510k Number | K911058 |
| Device Name: | TECHMEDICA CAD/CAM CUSTOM HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| Contact | Richard Cudworth |
| Correspondent | Richard Cudworth TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-08 |
| Decision Date | 1993-02-23 |