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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, Lumbar
510(k) Number K173947
Device Name Lumbar Interbody Fusion System (OLLIF)
Applicant
Advanced Research Medical, LLC
1519 Hwy. 13 E.
Burnsville,  MN  55337
Applicant Contact John D Siegel
Correspondent
Qpc Services, LLC
537 N. Spencer
Mesa,  AZ  85203
Correspondent Contact James A. Dunning
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/27/2017
Decision Date 07/25/2018
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
Recalls CDRH Recalls
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