QUADRANT RETRACTOR SYSTEM— 510(k) K043602

Substantially Equivalent

Medtronic Sofamor Danek

FDA 510(k) clearance K043602 for QUADRANT RETRACTOR SYSTEM, Substantially Equivalent on 2005-02-23. Applicant: Medtronic Sofamor Danek.

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 2004-12-29
Decision date: 2005-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.