GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System— 510(k) K210534

Substantially Equivalent

Gramercy Extremity Orthopedics, LLC

FDA 510(k) clearance K210534 for GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System, Substantially Equivalent on 2021-03-26. Applicant: Gramercy Extremity Orthopedics, LLC.

Clearance details

Applicant: Gramercy Extremity Orthopedics, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2021-02-24
Decision date: 2021-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.