Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER

Fastener, Fixation, Nondegradable, Soft Tissue

ARTHROCARE CORPORATION

The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Q-fix Suture Anchor,1.8mm And 2.8mm / Drill, Drill Guide And Obturator,1.8mm And 2.8mm /bone Punch,2.8mm And Knot Pusher.

Pre-market Notification Details

Device IDK132513
510k NumberK132513
Device Name:Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin,  TX  78735 -0000
ContactMitchell Dhority
CorrespondentMitchell Dhority
ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin,  TX  78735 -0000
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-12
Decision Date2013-09-19
Summary:summary

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