ARTHREX BIO-POST AND WASHER

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 Bio-post And Washer.

Pre-market Notification Details

Device IDK011495
510k NumberK011495
Device Name:ARTHREX BIO-POST AND WASHER
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples,  FL  34104
ContactAnn Waterhouse
CorrespondentAnn Waterhouse
ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples,  FL  34104
Product CodeMAI  
Subsequent Product CodeHWC
Subsequent Product CodeJDR
Subsequent Product CodeMNU
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-15
Decision Date2001-08-01
Summary:summary

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