The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Profile Hip Acetabulum Prosthesis.
| Device ID | K863184 |
| 510k Number | K863184 |
| Device Name: | PROFILE HIP ACETABULUM PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Steve Wentworth |
| Correspondent | Steve Wentworth DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-19 |
| Decision Date | 1987-01-15 |