510(k) K242806

Medyssey Navigation System by Medyssey Co, Ltd. — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 16, 2025
Date Received: September 17, 2024
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.

Other clearances by Medyssey Co, Ltd.

K121670 — MEDYSSEY CANNULATED PEDICLE SCREW (January 25, 2013)
K121320 — C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE (August 10, 2012)
K121246 — MEDYSSY LT CAGE SYSTEM (June 15, 2012)
K110284 — NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM (June 8, 2011)
K110283 — ZENIUS SPINAL SYSTEM (May 19, 2011)
K110067 — LP CAGE (April 8, 2011)
K103272 — ZENIUS SPINAL SYSTEM (December 29, 2010)
K103147 — NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM (December 16, 2010)
K093104 — MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM (June 25, 2010)
K081153 — NOVEL SPINAL SYSTEM (January 30, 2009)

Other clearances for product code OLO

K260011 — Foundation Surgical Navigated Lateral Disc Prep Instruments (April 16, 2026)
K254158 — SPINEART Navigation Instrument System (April 9, 2026)
K260240 — SYMPHONY Navigation Ready Instruments (March 27, 2026)
K260601 — REAL INTELLIGENCE CORI (March 26, 2026)
K252037 — CUVIS-joint (CJ150) (March 25, 2026)
K253604 — TiLink-L Navigation Instruments (March 20, 2026)
K253444 — EUROPA Posterior Cervical Fusion Navigated Instruments (March 18, 2026)
K260546 — Q Pedicle Instruments (March 17, 2026)
K260010 — TMINI® Miniature Robotic System (March 3, 2026)
K260222 — Mako Total Knee Application (February 25, 2026)