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FDA 510(k) Application Details - K122533
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K122533
Device Name
Cement, Bone, Vertebroplasty
Applicant
OSSEON THERAPEUTICS, INC.
2330 CIRCADIAN WAY
SANTA ROSA, CA 95407 US
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Contact
KEITH BURGER
Other 510(k) Applications for this Contact
Regulation Number
888.3027
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Classification Product Code
NDN
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More FDA Info for this Product Code
Date Received
08/20/2012
Decision Date
10/23/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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