510(k) K240049

LINK(TM) External Fixator by Metric Medical Devices, Inc. — Product Code KTT

K240049 is an FDA 510(k) premarket notification submitted by Metric Medical Devices, Inc. for the device "LINK(TM) External Fixator". The FDA issued a decision of Substantially Equivalent on May 29, 2024. 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. Metric Medical Devices, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2024
Date Received
January 8, 2024
Clearance Type
Traditional
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