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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K230329
Device Name F3D Interbody System
Applicant
Corelink, LLC
2072 Fenton Logistics Blvd.
St. Louis,  MO  63026
Applicant Contact Steven Mounts
Correspondent
MCRA
803 7th Street NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   MQP   OVD   OVE   PLR  
Date Received02/06/2023
Decision Date 06/06/2023
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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