Cleared Traditional

Tyber Medical Trauma Screw

K252901 · Tyber Medical, LLC · Orthopedic
Dec 2025
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K252901 is an FDA 510(k) clearance for the Tyber Medical Trauma Screw, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on December 31, 2025, 111 days after receiving the submission on September 11, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K252901 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2025
Decision Date December 31, 2025
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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