ARTHREX CROSSPIN, MODEL AR-1964P

Pin, Fixation, Smooth

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Crosspin, Model Ar-1964p.

Pre-market Notification Details

Device IDK063719
510k NumberK063719
Device Name:ARTHREX CROSSPIN, MODEL AR-1964P
ClassificationPin, Fixation, Smooth
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactAnn Waterhouse
CorrespondentAnn Waterhouse
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-15
Decision Date2007-03-06
Summary:summary

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