510(k) K023564— OSSE-LIGN

Substantially Equivalent

Osseus, LLC

Clearance details

Applicant: Osseus, LLC
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2002-10-23
Decision date: 2003-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrenceville, NJ, US

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.