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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, Lumbar
510(k) Number K151665
Device Name SUSTAIN Additional Implants
Applicant
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact KELLY J BAKER
Correspondent
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact KELLY J BAKER
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/19/2015
Decision Date 03/16/2016
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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