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510(k) K261410

Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) by Suite 201, National Innovation Centre — Product Code OLO

K261410 is an FDA 510(k) premarket notification submitted by Suite 201, National Innovation Centre for the device "Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))". The FDA issued a decision of Substantially Equivalent on July 30, 2026. 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
July 30, 2026
Date Received
April 30, 2026
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 for product code OLO

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  • K262121 — Ion-L Navigated Instruments (July 24, 2026)
  • K261024 — TMINI Miniature Robotic System (July 24, 2026)
  • K261113 — Op.n™ Spine Navigation and Robotic Guidance (July 22, 2026)
  • K261852 — OTS Hip (July 1, 2026)
  • K253921 — VERTICALE® Navigation Instruments (June 26, 2026)
  • K260480 — VELYS™ Robotic-Assisted Solution (June 25, 2026)
  • K260369 — Dynamis Robotic Surgical System (June 20, 2026)
  • K261665 — CORUS™ Navigation System-GN (June 18, 2026)
  • K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (June 2, 2026)

FDA data resources