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510(k) K223108

TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) by Medos International SARL — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2023
Date Received
September 30, 2022
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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  • K252873 — Q Interbody Instruments (February 6, 2026)
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