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FDA 510(k) Application Details - K171434
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K171434
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Silony Medical GmbH
Leinfelder Strasse 60
Leinfelden-Echterdingen 70771 DE
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Contact
Bircan Yilmaz
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
05/15/2017
Decision Date
12/21/2017
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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