The following data is part of a premarket notification filed by Depuy International, Ltd with the FDA for Depuy 3d Additive Triflange Acetabular Cup.
| Device ID | K201348 |
| 510k Number | K201348 |
| Device Name: | DePuy 3D Additive TriFlange Acetabular Cup |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DePuy International, Ltd St. Anthony's Road Leeds, GB LS11 8DT |
| Contact | Erin Combs |
| Correspondent | Reily Inman DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-21 |
| Decision Date | 2022-06-16 |