The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Duraloc Option Acetabular Cup System, Models 1599-01-044 To -066, 1599-11-044 To -062 And 1599-21-044 To -062.
| Device ID | K040544 |
| 510k Number | K040544 |
| Device Name: | DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582 |
| Contact | Dina L Weissman |
| Correspondent | Dina L Weissman DEPUY, INC. 700 ORTHOPAEDIC DR. 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 | 2004-03-02 |
| Decision Date | 2004-05-28 |
| Summary: | summary |