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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, cervical
510(k) Number K200429
Device Name BEE Cages
NGMedical GmbH
Talsperrenblick 5
nonnweiler,  DE 66620
Applicant Contact stella hahn
MRC Global
9085 East Mineral Circle, Suite 110
centennial,  CO  80112
Correspondent Contact christine scifert
Regulation Number888.3080
Classification Product Code
Date Received02/21/2020
Decision Date 01/29/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No