Medical Device Manufacturer · US , Morristown , NJ

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

29 submissions · 29 cleared · Since 2013

Recent clearances: Navigated LLIF Impactable Tracker, Tyber Medical Trauma Screw, Tyber Medical Trauma Screw

Official Website
29
Total
29
Cleared
0
Denied

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

29 devices
1-12 of 29
Cleared May 29, 2026
Navigated LLIF Impactable Tracker
K261060 · OLO
Orthopedic · 59d
Cleared Apr 03, 2026
Tyber Medical Trauma Screw
K253042 · HWC
Orthopedic · 193d
Cleared Dec 31, 2025
Tyber Medical Trauma Screw
K252901 · HWC
Orthopedic · 111d
Cleared Oct 28, 2025
Navigated Instruments
K252742 · OLO
Orthopedic · 61d
Cleared Jul 30, 2025
Tyber Medical Distal Radius Plating System
K251361 · HRS
Orthopedic · 90d
Cleared Mar 19, 2025
Tyber Medical Anatomical Plating System
K242486 · HRS
Orthopedic · 210d
Cleared May 31, 2024
Tyber Medical Anatomical Plating System
K241218 · HRS
Orthopedic · 30d
Cleared Dec 21, 2023
Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System
K233423 · HRS
Orthopedic · 72d
Cleared Dec 20, 2023
TM Plating System
K233017 · HRS
Orthopedic · 89d
Cleared Dec 13, 2023
Anatomical Plating System (various)
K232652 · HRS
Orthopedic · 104d
Cleared Dec 04, 2023
Tyber Medical Distal Radius Plating System
K232693 · HRS
Orthopedic · 90d
Cleared Jul 06, 2023
Tyber Medical Pin and Wire System (various)
K231339 · HTY
Orthopedic · 59d
Filters
Filter by Specialty
All29 Orthopedic 29