SPINEART Navigation Instrument System— 510(k) K210472

Clearance details

Applicant

Spineart

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2021-02-17

Decision date

2021-03-19

Decision

Substantially Equivalent

Clearance type

Special

Location

Plan Les Ouates, CH

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• K261205 — SPINEART Navigation Instrument System2026-07-29
• K261024 — TMINI Miniature Robotic System2026-07-24
• K262121 — Ion-L Navigated Instruments2026-07-24

• K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement2023-06-23
• K213470 — PERLA® TL Posterior Osteosynthesis System2022-01-21
• K203506 — PERLA® TL posterior osteosynthesis system2021-01-15
• K203222 — PERLA TL Posterior Osteosynthesis System2020-12-17
• K200571 — PERLA® Posterior Occipito-Cervico-Thoracic Fixation System2020-05-01

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 →