OPENING/CLOSING WEDGE OSTETOMY PLATES

Plate, Fixation, Bone

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Opening/closing Wedge Ostetomy Plates.

Pre-market Notification Details

Device IDK014155
510k NumberK014155
Device Name:OPENING/CLOSING WEDGE OSTETOMY PLATES
ClassificationPlate, 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 CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-19
Decision Date2002-03-18
Summary:summary

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