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FDA 510(k) Application Details - K031399
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K031399
Device Name
Filler, Bone Void, Calcium Compound
Applicant
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
Other 510(k) Applications for this Company
Contact
MARK LOAR
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/05/2003
Decision Date
02/18/2005
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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