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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K220658
Device Name COSY Cervicothoracic Occipital Rod-Screw System
Applicant
Signus Medizintechnik GmbH
Industriestraße 2
Alzenau,  DE 63755
Applicant Contact Holger Noss
Correspondent
Signus Medizintechnik GmbH
Industriestraße 2
Alzenau,  DE 63755
Correspondent Contact Holger Noss
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received03/07/2022
Decision Date 11/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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