PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Pinnacle Metal-on-metal Acetabular Cup Liners.

Pre-market Notification Details

Device IDK002883
510k NumberK002883
Device Name:PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactCheryl K Hastings
CorrespondentCheryl K Hastings
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeKWA  
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-15
Decision Date2000-10-13
Summary:summary

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