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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sacroiliac joint fixation
510(k) Number K183119
Device Name SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments
Applicant
Globus Medical Inc.
Valley Forge Business Center
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Lori Burns
Correspondent
Globus Medical Inc.
Valley Forge Business Center
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Lori Burns
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Code
OLO  
Date Received11/09/2018
Decision Date 02/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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