ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS

Screw, Fixation, Bone

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Titanium And Bio-degradable (polymer) Implants.

Pre-market Notification Details

Device IDK053338
510k NumberK053338
Device Name:ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
ClassificationScrew, Fixation, Bone
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactAnn Waterhouse
CorrespondentAnn Waterhouse
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeHWC  
Subsequent Product CodeMAI
Subsequent Product CodeMBI
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-01
Decision Date2006-01-26
Summary:summary

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