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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 integrated fixation, lumbar
510(k) Number K201087
Device Name CORBEL Spacers
Applicant
Globus Medical, Inc.
Valley Forge Business Center
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Jennifer Antonacci
Correspondent
Globus Medical, Inc.
Valley Forge Business Center
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Jennifer Antonacci
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received04/23/2020
Decision Date 07/31/2020
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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