osteo-WEDGE II ® Open Wedge Bone Locking Plate System— 510(k) K162179

Substantially Equivalent

Graham Medical Technologies, LLC Dba Gramedica

FDA 510(k) clearance K162179 for osteo-WEDGE II ® Open Wedge Bone Locking Plate System, Substantially Equivalent on 2017-01-10. Applicant: Graham Medical Technologies, LLC Dba Gramedica.

Clearance details

Applicant: Graham Medical Technologies, LLC Dba Gramedica
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2016-08-04
Decision date: 2017-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Macomb, MI, 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.