Apollo Ankle Fracture Plating System— 510(k) K213005

Substantially Equivalent

Glw Medical, Inc.

FDA 510(k) clearance K213005 for Apollo Ankle Fracture Plating System, Substantially Equivalent on 2022-03-11. Applicant: Glw Medical, Inc..

Clearance details

Applicant: Glw Medical, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2021-09-20
Decision date: 2022-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood Cliff, NJ, 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.