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FDA 510(k) Application Details - K162764
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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510(K) Number
K162764
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
IMPLANET S.A.
TECHNOPOLE BORDEAUX MONTESQUIEU
ALLEE FRANCOIS MAGENDIE
MARTILLAC 33650 FR
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REGIS LE COUEDIC
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Regulation Number
888.3070
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Classification Product Code
NKB
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Date Received
09/30/2016
Decision Date
01/19/2017
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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