510(k) K214059

CoreLink Navigation Instruments by Corelink, LLC — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 19, 2022
Date Received: December 27, 2021
Clearance Type: Special
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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