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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K163602
Device Name Kepler I Cervical Plate System
Applicant
Orbbo Surgical, LLC
555 W. 5th St., 35th
Los Angeles,  CA  90013
Applicant Contact Eric Garofano
Correspondent
Novus Management Group, LLC
6686 Dimmick Rd.
West Chester,  OH  45069
Correspondent Contact Tamala J. Wampler
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/21/2016
Decision Date 02/16/2017
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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