The following data is part of a premarket notification filed by Hayes Medical, Inc. with the FDA for Consensus Hip System, Unisyn Hip System.
| Device ID | K030151 |
| 510k Number | K030151 |
| Device Name: | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HAYES MEDICAL, INC. 1115 WINDFIELD WAY, SUITE 100 El Dorado Hills, CA 95762 -9623 |
| Contact | William J Griffin |
| Correspondent | William J Griffin HAYES MEDICAL, INC. 1115 WINDFIELD WAY, SUITE 100 El Dorado Hills, CA 95762 -9623 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-15 |
| Decision Date | 2003-04-10 |