510(k) K231922

DEPUY SYNTHES MAXFRAME AUTOSTRUT System by DePuy Synthes — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2023
Date Received
June 29, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type