The following data is part of a premarket notification filed by Hayes Medical, Inc. with the FDA for Consensus Femoral Component, Porous, Cocr/ti.
| Device ID | K983004 |
| 510k Number | K983004 |
| Device Name: | CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HAYES MEDICAL, INC. 819 STRIKER AVE. SUITE 10 Sacramento, CA 95834 -1129 |
| Contact | John B Stassi |
| Correspondent | John B Stassi HAYES MEDICAL, INC. 819 STRIKER AVE. SUITE 10 Sacramento, CA 95834 -1129 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-28 |
| Decision Date | 1998-11-25 |
| Summary: | summary |