ORTHONE— 510(k) K001773

Substantially Equivalent

Oni, Inc.

FDA 510(k) clearance K001773 for ORTHONE, Substantially Equivalent on 2000-08-18. Applicant: Oni, Inc..

Clearance details

Applicant: Oni, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2000-06-12
Decision date: 2000-08-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.