The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Actis Duofox Hip Prosthesis.
| Device ID | K150862 |
| 510k Number | K150862 |
| Device Name: | DePuy Actis Duofox Hip Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Contact | Correne Ramy |
| 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 | 2015-04-01 |
| Decision Date | 2015-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295394006 | K150862 | 000 |
| 10603295380771 | K150862 | 000 |
| 10603295380757 | K150862 | 000 |
| 10603295380740 | K150862 | 000 |
| 10603295380733 | K150862 | 000 |
| 10603295380726 | K150862 | 000 |
| 10603295380719 | K150862 | 000 |
| 10603295380702 | K150862 | 000 |
| 10603295380696 | K150862 | 000 |
| 10603295380689 | K150862 | 000 |
| 10603295380672 | K150862 | 000 |
| 10603295380665 | K150862 | 000 |
| 10603295380788 | K150862 | 000 |
| 10603295380795 | K150862 | 000 |
| 10603295380801 | K150862 | 000 |
| 10603295393993 | K150862 | 000 |
| 10603295393986 | K150862 | 000 |
| 10603295421054 | K150862 | 000 |
| 10603295421047 | K150862 | 000 |
| 10603295380870 | K150862 | 000 |
| 10603295380863 | K150862 | 000 |
| 10603295380856 | K150862 | 000 |
| 10603295380849 | K150862 | 000 |
| 10603295380832 | K150862 | 000 |
| 10603295380825 | K150862 | 000 |
| 10603295380818 | K150862 | 000 |
| 10603295380658 | K150862 | 000 |