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510(k) K142798

PASS LP Spinal System by Medicrea International SA — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2015
Date Received
September 29, 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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