The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Patella Prosthesis.
| Device ID | K840100 |
| 510k Number | K840100 |
| Device Name: | PATELLA PROSTHESIS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | TECHMEDICA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-10 |
| Decision Date | 1984-02-09 |