510(k) K223112

MAVERICK Mini External Fixation System by Smith & Nephew, Inc. — Product Code JDW

K223112 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "MAVERICK Mini External Fixation System". The FDA issued a decision of Substantially Equivalent on December 8, 2022. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2022
Date Received
October 3, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type