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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 K250092
Device Name HC Biologics Osteopoint Spinal Fixation System
Applicant
HC Biologics, LLC
1221 Brickell Ave.
Suite 900
Miami,  FL  33131
Applicant Contact Onur Basol
Correspondent
HC Biologics, LLC
1221 Brickell Ave.
Suite 900
Miami,  FL  33131
Correspondent Contact Onur Basol
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received01/14/2025
Decision Date 03/27/2025
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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