DeviceClearance

Product code OLO— Neurology

SPINEART Navigation Instrument System

Classification name
Orthopedic Stereotaxic Instrument
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
440
First cleared
Most recent

FDA classification definition

“Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.”

— U.S. Food and Drug Administration, device classification record for product code OLO under 21 CFR 882.4560, via openFDA

Market context for product code OLO

FDA has cleared 440 devices under product code OLO between 2009 and 2026, filed by 144 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OLO

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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OLO

1–100 of 440

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