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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K230394
Device Name EUROSCREW NG; EUROSCREW TCP NG
Applicant
Teknimed
11 Rue Apollo
L'Union,  FR 31240
Applicant Contact Fabian Marcq
Correspondent
RQMIS, Inc.
110 Haverhill Rd.
Suite 524
Amesbury,  MA  01913
Correspondent Contact Barry E Sands
Regulation Number888.3030
Classification Product Code
MAI  
Date Received02/14/2023
Decision Date 05/12/2023
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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