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510(k) K202184

Practical Navigation Surgical Guidance System (PNSGS) by Practical Navigation, LLC — Product Code OLO

K202184 is an FDA 510(k) premarket notification submitted by Practical Navigation, LLC for the device "Practical Navigation Surgical Guidance System (PNSGS)". The FDA issued a decision of Substantially Equivalent on Feb 24, 2021. 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
Feb 24, 2021
Date Received
Aug 4, 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
510(k)

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Other clearances for product code OLO

  • K262506 — Remex Spine Surgery Navigation - Universal Instruments (Aug 20, 2026)
  • K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral… (Jul 30, 2026)
  • K261205 — SPINEART Navigation Instrument System (Jul 29, 2026)
  • K261024 — TMINI Miniature Robotic System (Jul 24, 2026)
  • K262121 — Ion-L Navigated Instruments (Jul 24, 2026)
  • K261113 — Op.n™ Spine Navigation and Robotic Guidance (Jul 22, 2026)
  • K261852 — OTS Hip (Jul 1, 2026)
  • 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