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510(k) K140359

MAXIMIS SPINAL FIXATION SYSTEM by Valorem Surgical — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2015
Date Received
February 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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