510(k) K220181— StealthFix Intraosseous Fixation System

Substantially Equivalent

Nextremity Solutions, Inc.

Clearance details

Applicant: Nextremity Solutions, Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2022-01-21
Decision date: 2022-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.