Arthrex Vortex Threaded Bone Marrow Recovery Needle

Instrument, Biopsy

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Vortex Threaded Bone Marrow Recovery Needle.

Pre-market Notification Details

Device IDK213213
510k NumberK213213
Device Name:Arthrex Vortex Threaded Bone Marrow Recovery Needle
ClassificationInstrument, Biopsy
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactNick Moore
CorrespondentNick Moore
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-29
Decision Date2021-11-19

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