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FDA 510(k) Application Details - K122021
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K122021
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
SAFE ORTHOPAEDICS
PARC DES BELLEVUES- ALLEE
R LUXEMBOURG
ERAGNY SUR OISE 95610 FR
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Contact
P. DUMOUCHEL
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Regulation Number
888.3080
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Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
07/10/2012
Decision Date
09/20/2012
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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