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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K253858
Device Name GFS - Sterile Screws and Top Hat
Applicant
T.A.G. Medical Products Corporation, Ltd.
Kibbutz Gaaton
Gaaton Northern,  IL 2513000
Applicant Contact Shlomi Dines
Correspondent
T.A.G. Medical Products Corporation, Ltd.
Kibbutz Gaaton
Gaaton Northern,  IL 2513000
Correspondent Contact Shlomi Dines
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/03/2025
Decision Date 08/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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