LOW PROFILE SCREWS

Screw, Fixation, Bone

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Low Profile Screws.

Pre-market Notification Details

Device IDK103705
510k NumberK103705
Device Name:LOW PROFILE SCREWS
ClassificationScrew, Fixation, Bone
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactCourtney Smith
CorrespondentCourtney Smith
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-20
Decision Date2011-03-18
Summary:summary

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