Spine Guidance Software (Version 5.1) +4 more— 510(k) K241171

Clearance details

Device name as filed

Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories

Applicant

Stryker Leibinger GmbH & Co KG

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2024-04-26

Decision date

2024-07-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Freiburg Baden-Wurttemberg, DE

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• K261054 — RibPlate System2026-07-01
• K254233 — MEDPOR Customized Implant Kit2026-03-12
• K253623 — Spine Guidance 5.4 Software +9 more2026-02-19
• K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories2026-02-06
• K243491 — SternalPlate Expansion2024-12-11

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →