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FDA 510(k) Application Details - K060061
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K060061
Device Name
Filler, Bone Void, Calcium Compound
Applicant
STRYKER CORP.
750 TRADE CENTRE WAY
SUITE 200
KALAMAZOO, MI 49001 US
Other 510(k) Applications for this Company
Contact
WADE T RUTKOSKIE
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
01/09/2006
Decision Date
03/01/2006
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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