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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 K122533
Device Name OSSEOFLEX SB INFLATABLE BONE TAMP
Original Applicant
OSSEON THERAPEUTICS, INC.
2330 circadian way
santa rosa,  CA  95407
Original Contact keith burger
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received08/20/2012
Decision Date 10/23/2012
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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