GMA 2.0 Pedicle Screw System— 510(k) K192915

Substantially Equivalent

Grafton Medical Alliance

FDA 510(k) clearance K192915 for GMA 2.0 Pedicle Screw System, Substantially Equivalent on 2019-11-13. Applicant: Grafton Medical Alliance.

Clearance details

Applicant: Grafton Medical Alliance
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2019-10-15
Decision date: 2019-11-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Burr Ridge, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.