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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 K213614
Device Name Cannulated Screws
Applicant
Maxxion Medical, LLC
201, S. Biscayne Blvd., Suite 1200
Miami,  FL  33131
Applicant Contact Guilherme Esteves Pontes
Correspondent
Maxxion Medical, LLC
201, S. Biscayne Blvd., Suite 1200
Miami,  FL  33131
Correspondent Contact Guilherme Esteves Pontes
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received11/15/2021
Decision Date 08/03/2022
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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