Arthrex DynaNite Nitinol Staples

Staple, Fixation, Bone

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Dynanite Nitinol Staples.

Pre-market Notification Details

Device IDK203180
510k NumberK203180
Device Name:Arthrex DynaNite Nitinol Staples
ClassificationStaple, 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 CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-26
Decision Date2020-12-16

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.