Spine Navigation and Robotic-Assistance Device— 510(k) K233228

Clearance details

Applicant

Ecential Robotics

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2023-09-28

Decision date

2024-06-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gieres, FR

• 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

• K261113 — Op.n Spine Navigation and Robotic Guidance2026-07-22
• K242914 — Op.n(TM) Navigation2025-03-07
• K231886 — SURGIVISIO Device2023-07-27
• K221028 — SURGIVISIO Device2022-07-06
• K220946 — SURGIVISIO Device2022-04-15

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 →

• Z-3088-2026 — Velys Enabling Tech Robotic-Assist Station REF: 451611001Class II·Ongoing·Medos International Sarl·20260723

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233228.