ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Accolade Tmzf Ha 132 Degree Size 0 Hip Stem.

Pre-market Notification Details

Device IDK020572
510k NumberK020572
Device Name:ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
ContactNancy J Rieder
CorrespondentNancy J Rieder
HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale,  NJ  07401 -1677
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-21
Decision Date2002-03-04
Summary:summary

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