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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 Road 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
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