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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 K191709
Device Name V-STRUT Vertebral Implant
Applicant
Hyprevention Sas
Ptib - Hopital Xavier Arnozan - Ave. Du Haut-Leveque
Pessac Cedex,  FR 33604
Applicant Contact Cecile Vienney
Correspondent
Hyprevention, Inc.
1411 Broadway, 16th Floor
New York,  NY  10018
Correspondent Contact Cecile Vivez Vienney
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
LOD  
Date Received06/26/2019
Decision Date 03/05/2020
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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