The following data is part of a premarket notification filed by Depuy Orthopaedics Inc. with the FDA for Actis Duofix Hip Prosthesis.
| Device ID | K202472 |
| 510k Number | K202472 |
| Device Name: | ACTIS Duofix Hip Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Contact | Karen Mahoney |
| Correspondent | Ann Geraghty DePuy Ireland Loughbeg Ringaskiddy Cork, IE P43ed82 |
| Product Code | LPH |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-28 |
| Decision Date | 2020-10-21 |