The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Pinnacle Altrx Acetabular Liners.
Device ID | K102423 |
510k Number | K102423 |
Device Name: | DEPUY PINNACLE ALTRX ACETABULAR LINERS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Brandon Hipsher |
Correspondent | Brandon Hipsher DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-25 |
Decision Date | 2010-10-29 |
Summary: | summary |