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510(k) K203816

DeGen Navigated Instrumentation by Degen Medical — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2021
Date Received
December 29, 2020
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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