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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 K192915
Device Name GMA 2.0 Pedicle Screw System
Applicant
Grafton Medical Alliance
7416 Country Line Rd. Suite E
Burr Ridge,  IL  60527
Applicant Contact James Henry
Correspondent
Jalex Medical
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Cassie Sopko
Regulation Number888.3070
Classification Product Code
NKB  
Date Received10/15/2019
Decision Date 11/13/2019
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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