The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Actis Duofix Hip Prosthesis- Collarless.
| Device ID | K210581 |
| 510k Number | K210581 |
| Device Name: | Actis DuoFix Hip Prosthesis- Collarless |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | DePuy Ireland UC Loughbeg Ringaskiddy, IE |
| Contact | Elaine Pears |
| Correspondent | Erin Combs Depuy Orthopaedics, Inc 700 Orthopaedic Drive Warsaw, IN 46582 |
| Product Code | MEH |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2021-05-20 |