The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Gross Hip Femoral Component.
| Device ID | K904737 |
| 510k Number | K904737 |
| Device Name: | GROSS HIP FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. Braintree, MA 02184 |
| Contact | J Stone |
| Correspondent | J Stone JOHNSON & JOHNSON ORTHOPAEDICS, INC. Braintree, MA 02184 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-18 |
| Decision Date | 1991-07-26 |