Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2022-11-18 under approval 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. It is manufactured by Signus Medizintechnik GmbH. The 510(k) number is K220658.

When was COSY Cervicothoracic Occipital Rod-Screw System approved by the FDA?

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

What company makes COSY Cervicothoracic Occipital Rod-Screw System?

COSY Cervicothoracic Occipital Rod-Screw System is manufactured by Signus Medizintechnik GmbH.

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION

Other Devices by Signus Medizintechnik GmbH

K151704Diplomat® Spinal System K212755SIGNUS SACRONAIL® Transsacral Stabilization System K241438Signus Tetris™ St; Signus Tetris™ R St K243188CYLOX® ST

Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Official Source

View on FDA Database →

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

↑