ARTHREX INTERFERENCE SCREW

Fastener, Fixation, Biodegradable, Soft Tissue

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Interference Screw.

Pre-market Notification Details

Device IDK062466
510k NumberK062466
Device Name:ARTHREX INTERFERENCE SCREW
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactAnn Waterhouse
CorrespondentAnn Waterhouse
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeMAI  
Subsequent Product CodeHWC
Subsequent Product CodeMBI
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-24
Decision Date2006-11-29
Summary:summary

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