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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spinal vertebral body replacement device
510(k) Number K190147
Device Name COLOSSEUM Mesh
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 Number888.3060
Classification Product Code
MQP  
Subsequent Product Code
PLR  
Date Received01/29/2019
Decision Date 05/08/2019
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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