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Cohort Anterior Plate System APS

by Cohort Medical Products Group, Inc.

510(k) K950011

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)SN Traditional NumberK950011 Date6 Nov 1995DecidedStatusActive

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  • Withdrawn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)

Full name
Cohort(Tm) Anterior Plate System (Aps)
510(k) Number
FDA Product Code
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 22 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 Cohort Anterior Plate System is a spinal intervertebral body fixation appliance. It is designed to provide stabilization and fixation for the spine.

This device is identified by FDA 510(k) number K950011 and is classified under product code KWQ. It received FDA 510(k) clearance on November 6, 1995, following a determination of substantial equivalence for some indications.

Other devices from Cohort Medical Products Group, Inc.

Questions

AI-generated answers, 22 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 primary function of the Cohort Anterior Plate System?

    The Cohort Anterior Plate System is a spinal intervertebral body fixation appliance. It is specifically designed to provide stabilization and fixation for the spine during surgical procedures.

  • What is the regulatory status of this device?

    The Cohort Anterior Plate System received FDA 510(k) clearance on November 6, 1995, under the number K950011. This clearance was granted following a determination of substantial equivalence for some indications.

  • How is this device classified for regulatory purposes?

    The device is classified under product code KWQ and falls under the oversight of the Orthopedic advisory committee. This classification is used for administrative filing purposes to categorize the device type.