510(k) K113251

SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES by Synthes, Inc. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2011
Date Received
November 3, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type