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FDA 510(k) Application Details - K132817
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K132817
Device Name
Cement, Bone, Vertebroplasty
Applicant
BENVENUE MEDICAL, INC.
1171 BARROILHET DR.
HILLSBOROUGH, CA 94010 US
Other 510(k) Applications for this Company
Contact
CINDY DOMECUS, R.A.C. (US & EU)
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
NDN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2013
Decision Date
01/24/2014
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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