The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Ultima Fx Femoral Hip Stems.
| Device ID | K963885 |
| 510k Number | K963885 |
| Device Name: | ULTIMA FX FEMORAL HIP STEMS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | John Ferros |
| Correspondent | John Ferros JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-26 |
| Decision Date | 1996-12-09 |
| Summary: | summary |