The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Depuy Actis Duofix Hip Prosthesis.
| Device ID | K160907 |
| 510k Number | K160907 |
| Device Name: | DePuy Actis DuoFix Hip Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork, IE |
| Contact | Jaime Weeks |
| Correspondent | Correne Ramy 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 | 2016-04-01 |
| Decision Date | 2016-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295380764 | K160907 | 000 |
| 10603295380641 | K160907 | 000 |