The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Profile Femoral Hip.
| Device ID | K850055 |
| 510k Number | K850055 |
| Device Name: | PROFILE FEMORAL HIP |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Stephen M Doyle |
| Correspondent | Stephen M Doyle DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-08 |
| Decision Date | 1985-04-23 |