TRIDENT LARGE DIAMETER HIP SYSTEM

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

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Trident Large Diameter Hip System.

Pre-market Notification Details

Device IDK061434
510k NumberK061434
Device Name:TRIDENT LARGE DIAMETER HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactTiffani Rogers
CorrespondentTiffani Rogers
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeLPH  
Subsequent Product CodeJDI
Subsequent Product CodeLZO
Subsequent Product CodeMEH
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-24
Decision Date2006-08-22
Summary:summary

NIH GUDID Devices

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