The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Duraloc Cementless Acetabular Cup System.
| Device ID | K961186 |
| 510k Number | K961186 |
| Device Name: | DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Sally Foust |
| Correspondent | Sally Foust DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-26 |
| Decision Date | 1996-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295019732 | K961186 | 000 |
| 10603295019725 | K961186 | 000 |
| 10603295019718 | K961186 | 000 |
| 10603295019701 | K961186 | 000 |
| 10603295019695 | K961186 | 000 |