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K2M COCR Wire

by K2M, Inc.

510(k) K103797

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103797 Date20 May 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JDQ
Device class
Class II
Regulation
21 CFR Part 888.3010
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The K2M COCR Wire is a cerclage fixation device used in orthopedic procedures. It is designed to provide stabilization and support for bones during surgical interventions.

The device is supplied as a single-use item and is not intended for MRI environments. It is authorized under FDA 510K clearance with device class 2 and is regulated under number 888.3010. The device is available in various sizes as specified by the manufacturer.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the K2M COCR Wire used for in orthopedic procedures?

    The K2M COCR Wire is a cerclage fixation device designed to provide stabilization and support for bones during surgical interventions. It helps maintain proper alignment and fixation of bones during orthopedic procedures.

  • Is the K2M COCR Wire reusable or single-use?

    The K2M COCR Wire is supplied as a single-use item and is not intended for reuse. This ensures sterility and optimal performance for each patient, reducing the risk of cross-contamination between procedures.

  • What sizes are available for the K2M COCR Wire?

    The K2M COCR Wire is available in various sizes as specified by the manufacturer. The specific size options should be selected based on the clinical requirements of each individual surgical case to ensure proper fixation and support.

  • Can the K2M COCR Wire be used in MRI environments?

    No, the K2M COCR Wire is not intended for MRI environments. The device should not be used in patients who require MRI imaging due to potential interference with the imaging process.

  • What is the regulatory status of the K2M COCR Wire?

    The K2M COCR Wire is authorized under FDA 510K clearance with device class 2 and is regulated under number 888.3010. It received FDA clearance on May 20, 2011, with a decision code of SESE (Substantially Equivalent).