510(k) K213874

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

K213874 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "MAVERICK External Fixation System". The FDA issued a decision of Substantially Equivalent on February 11, 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
February 11, 2022
Date Received
December 13, 2021
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