The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for Ultima Tps Cemented Stem.
| Device ID | K965198 |
| 510k Number | K965198 |
| Device Name: | ULTIMA TPS CEMENTED STEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | JOHNSON & JOHNSON INTERNATIONAL 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Janet Johnson |
| Correspondent | Janet Johnson JOHNSON & JOHNSON INTERNATIONAL 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 | 1996-12-26 |
| Decision Date | 1997-07-23 |
| Summary: | summary |