The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Pinnacle Duofix Ha Acetabular Cup Prosthesis.
| Device ID | K192919 |
| 510k Number | K192919 |
| Device Name: | Pinnacle Duofix HA Acetabular Cup Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, IN 46582 |
| Contact | Kathy Harris |
| Correspondent | Margaret Shaughnessy DePuy (Ireland) Loughbeg, Ringakiddy Cork, IE P43d82 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-15 |
| Decision Date | 2019-11-26 |
| Summary: | summary |