Arthrex 2.5 Mm Tenodesis Screw

Screw, Fixation, Bone

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex 2.5 Mm Tenodesis Screw.

Pre-market Notification Details

Device IDK183395
510k NumberK183395
Device Name:Arthrex 2.5 Mm Tenodesis Screw
ClassificationScrew, Fixation, Bone
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactRebecca R. Homan
CorrespondentRebecca R. Homan
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-07
Decision Date2019-04-17

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