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510(k) K132412

INERTIA MIS PEDICLE SCREW SYSTEM by Nexxt Spine, LLC — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2013
Date Received
August 2, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code MNI

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