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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 STREET, SUITE 600
ST. PAUL,  MN  55128
Applicant Contact JACQUELINE A HAUGE
Correspondent
SPINEOLOGY INC.
7800 3RD STREET, 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
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