The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Ultima(tm) Total Hip System Cemented Femoral Stem.
| Device ID | K924379 |
| 510k Number | K924379 |
| Device Name: | ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-31 |
| Decision Date | 1993-02-12 |