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 | K173960 |
| 510k Number | K173960 |
| Device Name: | DePuy Corail AMT Hip Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DePuy France S.A.S. 7 Allee Irene Joliot Curie Bp256 Saint Priest Cedex Rhone-alpes, FR 69801 |
| Contact | David Holzwarth |
| Correspondent | Melissa Cook DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, IN 46582 |
| Product Code | LZO |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-28 |
| Decision Date | 2018-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295455448 | K173960 | 000 |
| 10603295455301 | K173960 | 000 |
| 10603295455295 | K173960 | 000 |
| 10603295455288 | K173960 | 000 |
| 10603295452546 | K173960 | 000 |
| 10603295452539 | K173960 | 000 |
| 10603295452522 | K173960 | 000 |
| 10603295446873 | K173960 | 000 |
| 10603295446866 | K173960 | 000 |
| 10603295446859 | K173960 | 000 |
| 10603295455318 | K173960 | 000 |
| 10603295455325 | K173960 | 000 |
| 10603295455431 | K173960 | 000 |
| 10603295455424 | K173960 | 000 |
| 10603295455400 | K173960 | 000 |
| 10603295455394 | K173960 | 000 |
| 10603295455387 | K173960 | 000 |
| 10603295455363 | K173960 | 000 |
| 10603295455356 | K173960 | 000 |
| 10603295455349 | K173960 | 000 |
| 10603295455332 | K173960 | 000 |
| 10603295446842 | K173960 | 000 |