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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 - Avenue du Haut-Leveque
PESSAC Cedex,  FR 33604
Applicant Contact Cecile Vienney
Correspondent
Hyprevention SAS
PTIB - Hopital Xavier Arnozan - Avenue du Haut-Leveque
PESSAC Cedex,  FR 33604
Correspondent Contact Cecile 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
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