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FDA 510(k) Application Details - K140359
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K140359
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
VALOREM SURGICAL
111 Hill Road
Douglassville, PA 19518 US
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Contact
PATRICK MOORE
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/12/2014
Decision Date
01/07/2015
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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