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FDA 510(k) Application Details - K151352
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K151352
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
MEDOS INTERNATIONAL SARL
CHEMIN-BLANC 38
LE LOCLE 2400 CH
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Contact
JEFFREY SHIFFMAN
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
05/20/2015
Decision Date
10/08/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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