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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K193219
Device Name G Surgical Marksman System
Applicant
G Surgical, LLC
9433 Bee Cave Rd. Bldg. 3, Suite 101-A
Austin,  TX  78733
Applicant Contact Donald Grafton
Correspondent
Backroads Consulting
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E Warden
Regulation Number888.3070
Classification Product Code
NKB  
Date Received11/21/2019
Decision Date 12/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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