MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM— 510(k) K050117

Substantially Equivalent

Medtronic Sofamor Danek

FDA 510(k) clearance K050117 for MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM, Substantially Equivalent on 2005-02-17. Applicant: Medtronic Sofamor Danek.

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2005-01-18
Decision date: 2005-02-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.