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510(k) K153273

MySpine Pedicle Screw Placement Guides - LP by Medacta International S.A. — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2016
Date Received
November 12, 2015
Clearance Type
Traditional
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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