BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B

Fastener, Fixation, Biodegradable, Soft Tissue

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Bio-fastak Suture Anchor, Model Ar-1324b.

Pre-market Notification Details

Device IDK000506
510k NumberK000506
Device Name:BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples,  FL  34104
ContactVernon Brown
CorrespondentVernon Brown
ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples,  FL  34104
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-15
Decision Date2000-05-01
Summary:summary

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