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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 K211769
Device Name OneLIF Intervertebral Body Replacement System
Applicant
NovApproach Spine
13900 Tech City Circle, Suite 300
Alachua,  FL  32615
Applicant Contact Ronald P. Green
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Meredith Lee May
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received06/08/2021
Decision Date 09/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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