The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for P.f.c. Hip System Non-porous Femoral Component.
| Device ID | K900638 |
| 510k Number | K900638 |
| Device Name: | P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | JOHNSON & JOHNSON INTERNATIONAL 100 BAY STATE DR. Braintree, MA 02184 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON INTERNATIONAL 100 BAY STATE DR. Braintree, MA 02184 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-09 |
| Decision Date | 1990-04-30 |