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FDA 510(k) Application Details - K112453
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K112453
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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
888.3070
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Classification Product Code
NKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/25/2011
Decision Date
11/15/2011
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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