PCA CONSTRAINED ACETABULAR LINERS

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Pca Constrained Acetabular Liners.

Pre-market Notification Details

Device IDK063445
510k NumberK063445
Device Name:PCA CONSTRAINED ACETABULAR LINERS
ClassificationProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactFrancisco Haro
CorrespondentFrancisco Haro
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeKWZ  
CFR Regulation Number888.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-15
Decision Date2007-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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