Home / 510(k) Clearances / K251943

510(k) K251943

Spineology Navigation Instruments by Spineology, Inc. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2025
Date Received
June 24, 2025
Clearance Type
Special
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 Spineology, Inc.

  • K251302 — OptiMesh Multiplanar Expandable Interbody Fusion System (December 15, 2025)
  • K230927 — OptiMesh Multiplanar Expandable Interbody Fusion System (November 1, 2023)
  • K231781 — OptiMesh Multiplanar Expandable Interbody Fusion System (October 18, 2023)
  • K213876 — Spineology Navigation Instruments (August 5, 2022)
  • K210155 — Duo Expandable Interbody Fusion System (February 19, 2021)
  • DEN200010 — Spineology Interbody Fusion System (September 18, 2020)
  • K192047 — Rampart™ One Lumbar Interbody Fusion System (August 23, 2019)
  • K191091 — Rampart One Lumbar Interbody Fusion System (May 23, 2019)
  • K190055 — Duo Lumbar Interbody Fusion Device (March 7, 2019)
  • K182322 — Duo Lumbar Interbody Fusion Device (October 24, 2018)

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)
  • 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)
  • K254148 — VERTICALE GPS Instruments (February 19, 2026)
  • K253381 — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (February 12, 2026)
  • K252873 — Q Interbody Instruments (February 6, 2026)
  • K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)
  • K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) (February 6, 2026)