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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 K251459
Device Name OneLIF™ Interbody Fusion System
Applicant
Novapproach Spine, LLC
13900 Tech City Circle
Suite 300
Alachua,  FL  32615
Applicant Contact Ron Green
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80901 8
Correspondent Contact Hannah Taggart
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received05/12/2025
Decision Date 06/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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