Home / 510(k) Clearances / K240662

510(k) K240662

Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece by Stryker Leibinger GmbH & Co KG — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2024
Date Received
March 8, 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 Stryker Leibinger GmbH & Co KG

  • K254233 — MEDPOR Customized Implant Kit (March 12, 2026)
  • K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
  • K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)
  • K243491 — SternalPlate Expansion (December 11, 2024)
  • K241517 — Q Guidance System; Mako Spine System; (August 27, 2024)
  • K241171 — Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CO (July 25, 2024)
  • K240651 — MRI Universal (July 12, 2024)
  • K233542 — Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Or (March 14, 2024)
  • K231599 — Stryker MP, Mandible, HMMF and MMF AXS Screws (August 24, 2023)
  • K231208 — Stryker Resorbable Fixation System (August 14, 2023)

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)