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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 Integrated Fixation, Lumbar
510(k) Number K251829
Device Name DeGen Medical Patient Specific Implant (PSI) System
Applicant
Degen Medical
1321-C N. Cashua Dr.
Florence,  SC  29501
Applicant Contact Craig Black
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy Suite 120
Woodstock,  GA  30188
Correspondent Contact Justin Gracyalny
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Codes
MAX   PHM  
Date Received06/13/2025
Decision Date 12/08/2025
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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