TriMAX Implant System— 510(k) K190722

Substantially Equivalent

Crossroads Extemity Systems, LLC

FDA 510(k) clearance K190722 for TriMAX Implant System, Substantially Equivalent on 2019-08-16. Applicant: Crossroads Extemity Systems, LLC.

Clearance details

Applicant: Crossroads Extemity Systems, LLC
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2019-03-20
Decision date: 2019-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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.