510(k) K241014

Biomet Kirschner Wires (K-Wires) by Biomet, Inc. — Product Code HTY

K241014 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "Biomet Kirschner Wires (K-Wires)". The FDA issued a decision of Substantially Equivalent on May 22, 2024. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Biomet, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2024
Date Received
April 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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