The following data is part of a premarket notification filed by Hayes Medical, Inc. with the FDA for 36mm Cocr Femoral Head And 36mm Acetabular Insert.
| Device ID | K070061 |
| 510k Number | K070061 |
| Device Name: | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | HAYES MEDICAL, INC. 1115 WINDFIELD WAY, SUITE 100 El Dorado Hills, CA 95762 -9623 |
| Contact | Luke Rose |
| Correspondent | Luke Rose HAYES MEDICAL, INC. 1115 WINDFIELD WAY, SUITE 100 El Dorado Hills, CA 95762 -9623 |
| Product Code | LWJ |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-05 |
| Decision Date | 2007-01-31 |
| Summary: | summary |