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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 K203278
Device Name INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers
Applicant
Globus Medical Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Kelly Baker
Correspondent
Globus Medical Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Kelly Baker
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
OVD  
Date Received11/06/2020
Decision Date 02/02/2021
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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