BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B

Washer, Bolt Nut

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Bi-cortical Bio-post And Washer, Model Ar-1367b.

Pre-market Notification Details

Device IDK043145
510k NumberK043145
Device Name:BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
ClassificationWasher, Bolt Nut
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactSally Foust
CorrespondentSally Foust
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-15
Decision Date2005-02-18
Summary:summary

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