The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Summit Duofix Ha Coating.
| Device ID | K193398 |
| 510k Number | K193398 |
| Device Name: | Summit DuoFix HA Coating |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Contact | Erin Combs |
| Correspondent | Margaret Shaughnessy DePuy (Ireland) Loughbeg, Ringaskiddy Cork, IE P43ed82 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-06 |
| Decision Date | 2020-02-04 |