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K2M COCR ROD

by K2M, Inc.

510(k) K080792

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 · Special NumberK080792 Date8 Apr 2008ClearedStatusActive

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  • Withdrawn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
MNI
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 ROD is a contoured deformity rod made of Cobalt-Chromium (CoCr) material with a dual hex design. It is part of the EVEREST® Spinal System and is used for stabilization of bony segments during surgical procedures.

This device is supplied in a size of Ø6.0x600 mm and is intended for single-use. It received FDA 510(k) clearance on April 8, 2008, with product code MNI and is classified under the orthopedic advisory committee.

Other devices from K2M, Inc.

See all devices from K2M, Inc. →

Questions

AI-generated answers, 1 Oct 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 ROD used for?

    The K2M COCR ROD is a contoured deformity rod made of Cobalt-Chromium material with a dual hex design. It is part of the EVEREST® Spinal System and is used for stabilization of bony segments during surgical procedures.

  • How is the K2M COCR ROD supplied?

    The device is supplied in a single size of Ø6.0x600 mm. It is intended for single-use only and should not be reused or resterilized for patient safety and device integrity reasons.

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

    The K2M COCR ROD received FDA 510(k) clearance on April 8, 2008, with product code MNI and is classified under the orthopedic advisory committee. It was determined to be substantially equivalent to predicate devices.

  • What material is the K2M COCR ROD made of?

    The K2M COCR ROD is made of Cobalt-Chromium (CoCr) material, which provides strength and durability for spinal stabilization procedures. The dual hex design enhances fixation and stability during surgical use.