DynaClip Bone Staple

Staple, Fixation, Bone

MedShape, Inc.

The following data is part of a premarket notification filed by Medshape, Inc. with the FDA for Dynaclip Bone Staple.

Pre-market Notification Details

Device IDK193305
510k NumberK193305
Device Name:DynaClip Bone Staple
ClassificationStaple, Fixation, Bone
Applicant MedShape, Inc. 1575 Northside Drive NW, Suite 440 Atlanta,  GA  30318
ContactJack Griffis
CorrespondentJack Griffis
MedShape, Inc. 1575 Northside Drive NW, Suite 440 Atlanta,  GA  30318
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-29
Decision Date2020-04-23

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