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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K192447
Device Name Superelastic Staple
Applicant
Neosteo
Malleve 2a, 1 Blvd. Jean Moulin
Nantes,  FR 44 100
Applicant Contact Anne-Cecile Grandremy
Correspondent
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Haven,  UT  84401
Correspondent Contact J.D Webb
Regulation Number888.3030
Classification Product Code
JDR  
Date Received09/06/2019
Decision Date 02/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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