The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Ultima Augmented Uhmwpe Cup.
| Device ID | K950563 |
| 510k Number | K950563 |
| Device Name: | ULTIMA AUGMENTED UHMWPE CUP |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Contact | J. T Dorriety |
| Correspondent | J. T Dorriety JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-08 |
| Decision Date | 1995-06-07 |