The following data is part of a premarket notification filed by Depuy Orthopaedics Inc. with the FDA for Depuy Corail Amt Hip Prosthesis.
| Device ID | K213839 |
| 510k Number | K213839 |
| Device Name: | DePuy Corail AMT Hip Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Contact | Erin Combs |
| Correspondent | Paul Shin DePuy (Ireland) Loughbeg, Ringaskiddy Cork, IE P43ed82 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-09 |
| Decision Date | 2022-01-06 |