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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 K122175
Device Name MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
Applicant
Tecres S.P.A.
7 Trl. House Ct.
Rockville,  MD  20850
Applicant Contact CHRISTINE BRAUER, PH.D.
Correspondent
Tecres S.P.A.
7 Trl. House Ct.
Rockville,  MD  20850
Correspondent Contact CHRISTINE BRAUER, PH.D.
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
LOD  
Date Received07/23/2012
Decision Date 03/28/2013
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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