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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 K260340
Device Name HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
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 Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   OVE  
Date Received02/02/2026
Decision Date 04/13/2026
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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