Medical Device Manufacturer · US , Morristown , NJ

Tyber Medical, LLC - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 2013

Recent clearances: Exalta Proximal Tibia Plating System, Anteralign LS coverplate, Navigated LLIF Impactable Tracker

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31

Total

31

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tyber Medical, LLC Orthopedic ✕

31 devices

1-12 of 31

Cleared Jun 12, 2026

Exalta Proximal Tibia Plating System

Orthopedic · 60d

Cleared Jun 10, 2026

Anteralign LS coverplate

Orthopedic · 90d

Cleared May 29, 2026

Navigated LLIF Impactable Tracker

Orthopedic · 59d

Cleared Apr 03, 2026

Tyber Medical Trauma Screw

Orthopedic · 193d

Cleared Dec 31, 2025

Tyber Medical Trauma Screw

Orthopedic · 111d

Cleared Oct 28, 2025

Navigated Instruments

Orthopedic · 61d

Cleared Jul 30, 2025

Tyber Medical Distal Radius Plating System

Orthopedic · 90d

Cleared Mar 19, 2025

Tyber Medical Anatomical Plating System

Orthopedic · 210d

Cleared May 31, 2024

Tyber Medical Anatomical Plating System

Orthopedic · 30d

Cleared Dec 21, 2023

Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System

Orthopedic · 72d

Cleared Dec 20, 2023

TM Plating System

Orthopedic · 89d

Cleared Dec 13, 2023

Anatomical Plating System (various)

Orthopedic · 104d