BIO-ABSORBABLE CORKSCREW MODEL AR-1920B

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-absorbable Corkscrew Model Ar-1920b.

Pre-market Notification Details

Device IDK003227
510k NumberK003227
Device Name:BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
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  
Subsequent Product CodeGAP
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-16
Decision Date2001-01-08

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