The following data is part of a premarket notification filed by Depuy France S.a.s. with the FDA for Depuy Corail Amt Hip Prosthesis.
| Device ID | K123991 |
| 510k Number | K123991 |
| Device Name: | DEPUY CORAIL AMT HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | DEPUY FRANCE S.A.S. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 |
| Contact | Alma Relja, Rac |
| Correspondent | Alma Relja, Rac DEPUY FRANCE S.A.S. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 |
| Product Code | KWY |
| Subsequent Product Code | KWL |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-09-16 |