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Cohort Discectomy Systems (CDS)

by Cohort Medical Products Group, Inc.

510(k) K964975

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 NumberK964975 Date24 Feb 1997ClearedStatusActive

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

Cohort Discectomy Systems (CDS) is a device used in orthopedic procedures, specifically for discectomy, as indicated by its device name and classification under product code HRX. It was determined to be substantially equivalent to a predicate device through the traditional 510(k) clearance pathway.

The system was cleared by the FDA under 510(k) number K964975 on February 24, 1997, following submission on December 12, 1996. It is manufactured by Cohort Medical Products Group, Inc., located in Hayward, California, and is classified under the Orthopedic review advisory committee (OR). No further details regarding sterility, single-use status, MRI safety, sizes, storage, or clinical indications are provided in the data.

Other devices from Cohort Medical Products Group, Inc.

Questions

AI-generated answers, 25 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 Cohort Discectomy Systems (CDS) used for?

    The Cohort Discectomy Systems (CDS) is used in orthopedic procedures, specifically for discectomy, as indicated by its device name and classification under product code HRX.

  • How was the Cohort Discectomy Systems (CDS) cleared for market?

    The Cohort Discectomy Systems (CDS) was determined to be substantially equivalent to a predicate device through the traditional 510(k) clearance pathway, as stated in its FDA authorization.

  • When was the Cohort Discectomy Systems (CDS) cleared by the FDA?

    The Cohort Discectomy Systems (CDS) was cleared by the FDA under 510(k) number K964975 on February 24, 1997, following submission on December 12, 1996.

  • Who manufactures the Cohort Discectomy Systems (CDS) and where are they located?

    The Cohort Discectomy Systems (CDS) is manufactured by Cohort Medical Products Group, Inc., located at 3583 Investment Blvd., #5, Hayward, California, 94545, United States.