Class Class II

Tyber Medical Anatomical Plating System (K222465)

K222465 2023-03-07 Traditional
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Description

Tyber Medical Anatomical Plating System by Tyber Medical, LLC, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222465
Clearance Date2023-03-07
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030

Categories

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Predicate lineage for K222465

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Tyber Medical Anatomical Plating System (K222465) cites 2 predicate devices and is itself cited by 3 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC2021
K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC2020

Later devices that cite this one as their predicate

Devices that cite K222465
K numberDeviceApplicantYear
K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC2025
K233423Tyber Medical Anatomical Plating System – Line extension to...Tyber Medical, LLC2023
K232652Anatomical Plating System (various)Tyber Medical, LLC2023

Trace the full predicate network for K222465

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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