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FDA 510(k) Application Details - K162864
Device Classification Name
Methyl Methacrylate For Cranioplasty
More FDA Info for this Device
510(K) Number
K162864
Device Name
Methyl Methacrylate For Cranioplasty
Applicant
Skeletal Kinetics, LLC.
10201 Bubb Road
Cupertino, CA 95014 US
Other 510(k) Applications for this Company
Contact
Alicia Hemphill
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
10/13/2016
Decision Date
01/13/2017
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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