The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Hydroxyapatite Coated Profile(r) Hip Stem.
| Device ID | K910156 |
| 510k Number | K910156 |
| Device Name: | HYDROXYAPATITE COATED PROFILE(R) HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Kim Tompkins |
| Correspondent | Kim Tompkins DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-14 |
| Decision Date | 1991-06-07 |