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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K161114
Device Name HIGH V+
Applicant
Teknimed Sas
11, Rue D'Apollo
L'Union,  FR 31240
Applicant Contact J.D. Webb
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J.D. Webb
Regulation Number888.3027
Classification Product Code
NDN  
Date Received04/20/2016
Decision Date 04/12/2017
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
Recalls CDRH Recalls
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