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510(k) K242933

SPINEART Navigation Instrument System by Spineart SA — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
September 25, 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 Spineart SA

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  • K242589 — Scarlet® AL-T (October 23, 2024)
  • K241644 — SPINEART Navigation Instrument System (August 7, 2024)
  • K241321 — Juliet® Ti LL Lumbar Interbody Device (July 18, 2024)
  • K240699 — SCARLET® AC-Ti (May 10, 2024)
  • K231069 — PERLA® TL Posterior Thoraco-lumbar Fixation System (October 25, 2023)
  • K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement (June 23, 2023)
  • K230583 — Tryptik Ti (March 22, 2023)
  • K213470 — PERLA® TL Posterior Osteosynthesis System (January 21, 2022)
  • K210472 — SPINEART Navigation Instrument System (March 19, 2021)

Other clearances for product code OLO

  • K260010 — TMINI® Miniature Robotic System (March 3, 2026)
  • K260222 — Mako Total Knee Application (February 25, 2026)
  • K252989 — “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (February 20, 2026)
  • K254148 — VERTICALE GPS Instruments (February 19, 2026)
  • K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For U (February 19, 2026)
  • K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
  • K253381 — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (February 12, 2026)
  • K252873 — Q Interbody Instruments (February 6, 2026)
  • K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) (February 6, 2026)
  • K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)