The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Ultima Unipolar Modular Head.
| Device ID | K940190 |
| 510k Number | K940190 |
| Device Name: | ULTIMA UNIPOLAR MODULAR HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON ORTHOPAEDICS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-13 |
| Decision Date | 1994-09-29 |