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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name growing rod system
510(k) Number K213196
Device Name MARVEL™ Growing Rods
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 Number888.3070
Classification Product Code
PGM  
Date Received09/29/2021
Decision Date 12/19/2022
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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