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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 integrated fixation, cervical
510(k) Number K210470
Device Name C-CURVE Interbody Fusion Device
Applicant
Medicrea International S. A.
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Applicant Contact Karine Trogneux
Correspondent
Medicrea International S. A.
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Correspondent Contact Karine Trogneux
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received02/17/2021
Decision Date 09/03/2021
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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