510(k) K231922

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

K231922 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "DEPUY SYNTHES MAXFRAME AUTOSTRUT System". The FDA issued a decision of Substantially Equivalent on July 26, 2023. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. DePuy Synthes has at least 10 other 510(k) clearances on record.

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