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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, Cervical
510(k) Number K142456
Device Name GPS Spacers
Applicant
G Surgical, LLC
5757 Central Ave., Suite G
Boulder,  CO  80301
Applicant Contact Donald Grafton
Correspondent
Backroads Consulting, Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E Warden, Ph.D
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received09/02/2014
Decision Date 04/10/2015
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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