PINNACLE ACETABULAR SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Pinnacle Acetabular System.

Pre-market Notification Details

Device IDK001534
510k NumberK001534
Device Name:PINNACLE ACETABULAR SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactLynnette Whitaker
CorrespondentLynnette Whitaker
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-17
Decision Date2000-06-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.