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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 K141419
Device Name ZVPLASTY
Applicant
Zavation, LLC
400 Liberty Park Dr.
Flowood,  MS  39232
Applicant Contact JOHN WALKER
Correspondent
Zavation, LLC
400 Liberty Park Dr.
Flowood,  MS  39232
Correspondent Contact JOHN WALKER
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Codes
GAA   HRX  
Date Received05/29/2014
Decision Date 09/12/2014
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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