Evolution Spine Navigation Instruments— 510(k) K250167

Name: FDA 510(k) clearance K250167
Creator: U.S. Food and Drug Administration
Published: 2025-08-18

Substantially Equivalent

Evolution Spine

FDA 510(k) clearance K250167 for Evolution Spine Navigation Instruments, Substantially Equivalent on 2025-08-18. Applicant: Evolution Spine. Device class: 2.

Clearance details

Applicant: Evolution Spine
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-01-21
Decision date: 2025-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

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K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
K261205 — SPINEART Navigation Instrument System2026-07-29
K261024 — TMINI Miniature Robotic System2026-07-24
K262121 — Ion-L Navigated Instruments2026-07-24

More clearances from Evolution Spine

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K262094 — E3D-C Interbody System2026-07-22
K260038 — E3D-C Interbody System2026-02-04
K241846 — E3D-C Interbody System2024-08-12
K240368 — E3D-A Interbody System2024-05-15
K232432 — E3D-A Interbody System2024-01-30

Adverse events under product code OLO

product code OLO

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.