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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement, Antibiotic
510(k) Number K242216
Device Name GENTAFIX® (1, 3, 3MV)
Applicant
Teknimed Sas
11-12 Rue D'Apollo
L'Union,  FR 31240
Applicant Contact Claudine Lavergne
Correspondent
RQMIS, Inc.
110 Haverhill Rd.
Suite 524
Amesbury,  MA  01913
Correspondent Contact Barry Sands
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Code
LOD  
Date Received07/29/2024
Decision Date 12/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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