MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS

Washer, Bolt Nut

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Mini Tightrope Repair Kit, Model Ar-8911ds.

Pre-market Notification Details

Device IDK061925
510k NumberK061925
Device Name:MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS
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 Received2006-07-07
Decision Date2006-10-31
Summary:summary

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