GEO Bone Screw System— 510(k) K161904

Substantially Equivalent

Gramercy Extremity Orthopeidics, LLC

FDA 510(k) clearance K161904 for GEO Bone Screw System, Substantially Equivalent on 2017-01-18. Applicant: Gramercy Extremity Orthopeidics, LLC.

Clearance details

Applicant: Gramercy Extremity Orthopeidics, LLC
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2016-07-11
Decision date: 2017-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.