Medical Device Manufacturer · US , Morristown , NJ

Tyber Medical, LLC

27 submissions · 27 cleared · Since 2013
27
Total
27
Cleared
0
Denied

Tyber Medical, LLC — FDA 510(k) Submissions

Tyber Medical, LLC has submitted 27 FDA 510(k) premarket notifications since 2013, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Screw, Fixation, Bone, Intervertebral Fusion Device With Bone Graft, Cervical, Bone Wedge, Pin, Fixation, Smooth . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
Tyber Medical Trauma Screw
K252901 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2025 111d
Navigated Instruments
K252742 · OLO Orthopedic Stereotaxic... · Orthopedic
Oct 2025 61d
Tyber Medical Distal Radius Plating System
K251361 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2025 90d
Tyber Medical Anatomical Plating System
K242486 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2025 210d
Tyber Medical Anatomical Plating System
K241218 · HRS Plate, Fixation, Bone · Orthopedic
May 2024 30d
Tyber Medical Anatomical Plating System ? Line extension to the Mini-Frag System
K233423 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2023 72d
TM Plating System
K233017 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2023 89d
Anatomical Plating System (various)
K232652 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2023 104d
Tyber Medical Distal Radius Plating System
K232693 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2023 90d
Tyber Medical Pin and Wire System (various)
K231339 · HTY Pin, Fixation, Smooth · Orthopedic
Jul 2023 59d
Tyber Medical Anatomical Plating System
K222465 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2023 204d
Tyber Medical Staple Fixation System (various)
K221947 · JDR Staple, Fixation, Bone · Orthopedic
Oct 2022 107d
Tyber Medical Anatomical Plating System
K203817 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2021 227d
Tyber Medical Anatomical Plating System
K193222 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2020 59d
Tyber Medical Trauma Screws
K192975 · HWC Screw, Fixation, Bone · Orthopedic
Jan 2020 77d
Tyber Medical Trauma Screw
K192974 · HWC Screw, Fixation, Bone · Orthopedic
Jan 2020 76d
Tyber Medical PT Interbody Spacer
K182284 · ODP Intervertebral Fusion... · Orthopedic
Jan 2019 148d
Tyber Medical PT Interbody Spacer System
K180590 · ODP Intervertebral Fusion... · Orthopedic
Jul 2018 122d
Tyber Medical PT Interbody Spacer System
K172185 · ODP Intervertebral Fusion... · Orthopedic
Dec 2017 154d
Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
K170571 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2017 113d
Tyber Medical Wedge System
K171327 · PLF Bone Wedge · Orthopedic
May 2017 11d
Tyber Medical BioTy? Nanotopography Trauma Screw
K161597 · HWC Screw, Fixation, Bone · Orthopedic
Nov 2016 160d
Tyber Medical Trauma Screw
K153575 · HWC Screw, Fixation, Bone · Orthopedic
Feb 2016 73d
Tyber Medical MST Trauma Screw
K153180 · HWC Screw, Fixation, Bone · Orthopedic
Nov 2015 22d
Tyber Medical Wedge System
K150394 · PLF Bone Wedge · Orthopedic
Jul 2015 160d
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