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FDA 510(k)

COHORT DISCECTOMY SYSTEMS (CDS)

K-Number: K964975 · 1997-02-24

ApplicantCohort Medical Products Group, Inc.
Decision Date1997-02-24
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COHORT DISCECTOMY SYSTEMS (CDS) is the device name listed in this FDA 510(k) record. The listed applicant is Cohort Medical Products Group, Inc.. It received FDA 510(k) clearance on 1997-02-24 under 510(k) number K964975. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COHORT DISCECTOMY SYSTEMS (CDS)?

COHORT DISCECTOMY SYSTEMS (CDS) is a medical device that received FDA 510(k) clearance on 1997-02-24. The listed applicant is Cohort Medical Products Group, Inc.. The 510(k) number is K964975.

When did COHORT DISCECTOMY SYSTEMS (CDS) receive FDA 510(k) clearance?

COHORT DISCECTOMY SYSTEMS (CDS) received FDA 510(k) clearance on 1997-02-24, under 510(k) number K964975.

Who is the listed applicant for COHORT DISCECTOMY SYSTEMS (CDS)?

The FDA 510(k) record lists Cohort Medical Products Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COHORT DISCECTOMY SYSTEMS (CDS)?

The FDA product code for COHORT DISCECTOMY SYSTEMS (CDS) is HRX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Cohort Medical Products Group, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950011COHORT(TM) ANTERIOR PLATE SYSTEM (APS)K943804BONE SCREWK943472COHORT AVB RETRACTOR SYSTEMK943474CANNULATED BONE SCREW

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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