TRIDENT CONSTRAINED ACETABULAR INSERT

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 Trident Constrained Acetabular Insert.

Pre-market Notification Details

Device IDK061654
510k NumberK061654
Device Name:TRIDENT CONSTRAINED ACETABULAR INSERT
ClassificationProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactJoseph Viola
CorrespondentJoseph Viola
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeKWZ  
CFR Regulation Number888.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-13
Decision Date2006-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327025606 K061654 000
07613327025453 K061654 000
07613327025460 K061654 000
07613327025477 K061654 000
07613327025484 K061654 000
07613327025491 K061654 000
07613327025507 K061654 000
07613327025514 K061654 000
07613327025538 K061654 000
07613327025545 K061654 000
07613327025552 K061654 000
07613327025569 K061654 000
07613327025576 K061654 000
07613327025583 K061654 000
07613327025590 K061654 000
07613327025446 K061654 000

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