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FDA 510(k) Application Details - K162912
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K162912
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
MEDOS INTERNATIONAL, SARL
CHEMIN-BLANC 38
LE LOCLE 2400 CH
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Contact
Karen Sylvia
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
10/17/2016
Decision Date
12/08/2016
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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