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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 K160906
Device Name Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device
Applicant
Spineology, Inc.
7800 3rd St., Suite 600
St. Paul,  MN  55128
Applicant Contact JACQUELINE A HAUGE
Correspondent
Spineology, Inc.
7800 3rd St., Suite 600
St. Paul,  MN  55128
Correspondent Contact JACQUELINE A HAUGE
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/01/2016
Decision Date 07/14/2016
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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