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510(k) K192653

Perseus by Orthokey Italia S.R.L. — Product Code OLO

K192653 is an FDA 510(k) premarket notification submitted by Orthokey Italia S.R.L. for the device "Perseus". The FDA issued a decision of Substantially Equivalent on Sep 9, 2020. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 9, 2020
Date Received
Sep 24, 2019
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
510(k)

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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  • K253921 — VERTICALE® Navigation Instruments (Jun 26, 2026)
  • K260480 — VELYS™ Robotic-Assisted Solution (Jun 25, 2026)
  • K260369 — Dynamis Robotic Surgical System (Jun 20, 2026)

FDA data resources