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CoLink PCR Plating System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213698

by In2Bones USA, LLC

Identifiers

510(k) Number
K213698 FDA 510(k)
FDA Product Code
HRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CoLink PCR Plating System is a single/multiple component metallic bone fixation appliance and accessory made from a carbon fiber reinforced PEEK polymer. This metal-free technology features long carbon fibers layered in alternating directions to provide high fatigue strength and enhanced performance.

The system is supplied as a Class II device under FDA 510(k) K213698 and is intended for orthopedic use. It is designed with customizable fiber orientation to optimize plating system performance and is available in various sizes and models.

Frequently asked questions

What is the CoLink PCR Plating System made of?

The CoLink PCR Plating System is a metallic bone fixation appliance and accessory made from a carbon fiber reinforced PEEK polymer, featuring long carbon fibers layered in alternating directions to provide high fatigue strength.

What sizes and models are available for the CoLink PCR Plating System?

The system is available in various sizes and models with customizable fiber orientation to optimize plating system performance for different orthopedic applications.

Is the CoLink PCR Plating System a single-use device?

The device is supplied as a Class II device under FDA 510(k) K213698 and is intended for orthopedic use, but the description does not specify whether it is single-use or reusable.

What is the regulatory status of the CoLink PCR Plating System?

The system is supplied as a Class II device under FDA 510(k) K213698 with a decision code of SESE (Substantially Equivalent) and was cleared on 2022-05-27.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CoLink PCR Plating System | CONMED, CoLink PCR Plating System (K213698) — FDA 510(k) | Innolitics, SP-18008-01_RevB_Colink PCR_ST_FINAL - CONMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
In2Bones USA, LLC

Sources (1)

  • FDA 510(k) K213698 24 fields · synced Sep 27, 2026