The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Depuy Corail Amt Hip Prosthesis.
| Device ID | K190344 |
| 510k Number | K190344 |
| Device Name: | DePuy Corail AMT Hip Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DePuy (Ireland) Loughbeg Ringaskiddy Co. Cork, IE |
| Contact | Kathy Harris |
| Correspondent | Melissa Cook DePuy Orthopaedics, Inc. 700 Orthopaedic Drive 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 | 2019-02-14 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295478713 | K190344 | 000 |
| 10603295478706 | K190344 | 000 |
| 10603295478690 | K190344 | 000 |
| 10603295478683 | K190344 | 000 |
| 10603295478652 | K190344 | 000 |
| 10603295478645 | K190344 | 000 |
| 10603295478638 | K190344 | 000 |
| 10603295478621 | K190344 | 000 |