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Cohen Distractor

by Howmedica Leibinger, Inc.

510(k) K972154

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972154 Date11 Aug 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Cohen Distractor is a Class II dental bone plate used in oral and maxillofacial surgical procedures. It is designed to provide temporary stabilization and distraction of bone segments during healing or reconstruction. The device is supplied by Howmedica Leibinger, Inc. and is regulated under product code JEY with an FDA 510(k) clearance.

This single-use, sterile device is intended for surgical settings and must be handled under aseptic conditions. It is not evaluated for MRI compatibility and should be stored in a dry, controlled environment. The device is authorized for distribution in the United States and is part of the manufacturer's portfolio of dental trauma and reconstruction implants.

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Questions

AI-generated answers, 24 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 Cohen Distractor used for?

    The Cohen Distractor is a Class II dental bone plate used in oral and maxillofacial surgical procedures. It is designed to provide temporary stabilization and distraction of bone segments during healing or reconstruction.

  • Is the Cohen Distractor supplied sterile and single-use?

    Yes, the Cohen Distractor is supplied as a single-use, sterile device intended for surgical settings and must be handled under aseptic conditions.

  • What are the storage requirements for the Cohen Distractor?

    The device should be stored in a dry, controlled environment. It is not evaluated for MRI compatibility, so storage should also avoid exposure to magnetic fields.

  • Which manufacturer produces the Cohen Distractor?

    The Cohen Distractor is manufactured by Howmedica Leibinger, Inc., a company that offers a portfolio of dental trauma and reconstruction implants.

  • What is the regulatory classification of the Cohen Distractor?

    The Cohen Distractor is a Class II medical device regulated under product code JEY. It received FDA 510(k) clearance as a traditional clearance with a substantially equivalent decision.