OSSE-LIGN— 510(k) K023564

Name: FDA 510(k) clearance K023564
Creator: U.S. Food and Drug Administration
Published: 2003-03-11

Substantially Equivalent

Osseus, LLC

FDA 510(k) clearance K023564 for OSSE-LIGN, Substantially Equivalent on 2003-03-11. Applicant: Osseus, LLC. Device class: 2.

Clearance details

Applicant: Osseus, LLC
Product code: Code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2002-10-23
Decision date: 2003-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrenceville, NJ, US

Download summary PDF View on FDA.gov ↗

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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.