510(k) K241563

Extremity Medical External Fixation System by Extremity Medical, LLC — Product Code KTT

K241563 is an FDA 510(k) premarket notification submitted by Extremity Medical, LLC for the device "Extremity Medical External Fixation System". The FDA issued a decision of Substantially Equivalent on February 21, 2025. 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. Extremity Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2025
Date Received
May 31, 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