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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 K140937
Device Name OSSEOFLEX SB
Applicant
Osseon, LLC
2330 Circadian Way
Santa Rosa,  CA  95407
Applicant Contact KEITH BURGER
Correspondent
Osseon, LLC
2330 Circadian Way
Santa Rosa,  CA  95407
Correspondent Contact KEITH BURGER
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received04/11/2014
Decision Date 06/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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