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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 K250560
Device Name BEE HA
Applicant
NGMedical GmbH
Trierer Strasse 65
Nonnweiler,  DE 66620
Applicant Contact Stella Hahn
Correspondent
MRC Global
9085 E. Mineral Cir
Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
ODP  
Date Received02/25/2025
Decision Date 11/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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