The following data is part of a premarket notification filed by Hayes Medical, Inc. with the FDA for Patient Specific Implant (psi) Hip Femoral Component.
| Device ID | K964395 |
| 510k Number | K964395 |
| Device Name: | PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HAYES MEDICAL, INC. 819 STRIKER AVE. SUITE 10 Sacramento, CA 95834 -1129 |
| Contact | Brian T Cleary |
| Correspondent | Brian T Cleary HAYES MEDICAL, INC. 819 STRIKER AVE. SUITE 10 Sacramento, CA 95834 -1129 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-04 |
| Decision Date | 1997-01-27 |
| Summary: | summary |