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FDA 510(k) Application Details - K133893
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K133893
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
SAFE ORTHOPAEDICS
Parc des Bellevues
Allee R.Luxembourg-Bat Californie
Eragny sur Oise 95610 FR
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Contact
PIERRE DUMOUCHEL
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
12/20/2013
Decision Date
03/14/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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