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 |