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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 K130146
Device Name SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
Applicant
Synthes (Usa), LLC
1302 Wrights Ln. E.
West Chester,  PA  19380
Applicant Contact STACEY BONNELL
Correspondent
Synthes (Usa), LLC
1302 Wrights Ln. E.
West Chester,  PA  19380
Correspondent Contact STACEY BONNELL
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received01/22/2013
Decision Date 05/20/2013
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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