TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55

Fastener, Fixation, Nondegradable, Soft Tissue

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Tenodesis Screw, 5.5 Mm, Model Ar-1350-55.

Pre-market Notification Details

Device IDK011007
510k NumberK011007
Device Name:TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
ClassificationFastener, Fixation, Nondegradable, 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 CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-04
Decision Date2001-06-12
Summary:summary

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