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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K212220
Device Name ArtFX Spinal Fixation System
Applicant
Artfx Medical, LLC
50 Laura St. #2524
Jacksonville,  FL  32202
Applicant Contact Ozgen Ozfidan
Correspondent
Artfx Medical, LLC
50 Laura St. #2524
Jacksonville,  FL  32202
Correspondent Contact Ozgen Ozfidan
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received07/16/2021
Decision Date 04/20/2023
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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