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510(k) K183644

Stealth-Midas MR8 System by Medtronic Powered Surgical Solutions — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2019
Date Received
December 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

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