Cleared Traditional

Tyber Medical Pin and Wire System (various)

K231339 · Tyber Medical, LLC · Orthopedic
Jul 2023
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K231339 is an FDA 510(k) clearance for the Tyber Medical Pin and Wire System (various), a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on July 6, 2023, 59 days after receiving the submission on May 8, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231339 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2023
Decision Date July 06, 2023
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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