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FDA 510(k)

COSY Cervicothoracic Occipital Rod-Screw System

K-Number: K220658 · 2022-11-18

ApplicantSignus Medizintechnik GmbH
Decision Date2022-11-18
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COSY Cervicothoracic Occipital Rod-Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K220658. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSY Cervicothoracic Occipital Rod-Screw System?

COSY Cervicothoracic Occipital Rod-Screw System is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K220658.

When did COSY Cervicothoracic Occipital Rod-Screw System receive FDA 510(k) clearance?

COSY Cervicothoracic Occipital Rod-Screw System received FDA 510(k) clearance on 2022-11-18, under 510(k) number K220658.

Who is the listed applicant for COSY Cervicothoracic Occipital Rod-Screw System?

The FDA 510(k) record lists Signus Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COSY Cervicothoracic Occipital Rod-Screw System?

The FDA product code for COSY Cervicothoracic Occipital Rod-Screw System is NKG.

Other records listing Signus Medizintechnik GmbH 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.

K243188CYLOX® STK241438Signus Tetris™ St; Signus Tetris™ R StK212755SIGNUS SACRONAIL® Transsacral Stabilization SystemK203327VERTACONNECT TLIF CageK151704Diplomat® Spinal System

Related Devices (Code: NKG)

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.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

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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