ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B

Screw, Fixation, Bone

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Bio-compression Screw, Small, Arthrex Bio-compression Screw, Large, Models Ar-5024b, Ar-5025b.

Pre-market Notification Details

Device IDK032098
510k NumberK032098
Device Name:ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B
ClassificationScrew, Fixation, Bone
Applicant ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples,  FL  34104
ContactAnn Waterhouse
CorrespondentAnn Waterhouse
ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples,  FL  34104
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-08
Decision Date2003-10-07
Summary:summary

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