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510(k) K201944

DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) by Synthes (USA) Products, LLC — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2020
Date Received
July 13, 2020
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

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