TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING

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 Porous Titanium Acetabular Component With Peri-apatite Coating.

Pre-market Notification Details

Device IDK013475
510k NumberK013475
Device Name:TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
ContactMargaret F Crowe
CorrespondentMargaret F Crowe
HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-19
Decision Date2001-12-20
Summary:summary

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