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FDA 510(k) Application Details - K060763
Device Classification Name
Methyl Methacrylate For Cranioplasty
More FDA Info for this Device
510(K) Number
K060763
Device Name
Methyl Methacrylate For Cranioplasty
Applicant
Stryker
750 TRADE CENTRE WAY
STE 200
PORTAGE, MI 49002 US
Other 510(k) Applications for this Company
Contact
WADE T RUTKOSKIE
Other 510(k) Applications for this Contact
Regulation Number
882.5300
More FDA Info for this Regulation Number
Classification Product Code
GXP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2006
Decision Date
09/22/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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