510(k) K231339

Tyber Medical Pin and Wire System (various) by Tyber Medical, LLC — Product Code HTY

K231339 is an FDA 510(k) premarket notification submitted by Tyber Medical, LLC for the device "Tyber Medical Pin and Wire System (various)". The FDA issued a decision of Substantially Equivalent on July 6, 2023. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Tyber Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2023
Date Received
May 8, 2023
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