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FDA 510(k) Application Details - K200316
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K200316
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Medicrea International S.A.
5389, route de Strasbourg
Rillieux-la-Pape 69140 FR
Other 510(k) Applications for this Company
Contact
David Ryan
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/07/2020
Decision Date
10/30/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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