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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K212433
Device Name Anthem Fracture System
Applicant
Globus Medical Inc.
2560 General Armistead Ave.
audubon,  PA  19403
Applicant Contact jennifer antonacci
Correspondent
Globus Medical Inc.
2560 General Armistead Ave.
audubon,  PA  19403
Correspondent Contact jennifer antonacci
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/04/2021
Decision Date 10/01/2021
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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