ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS— 510(k) K033109

Substantially Equivalent

Scient'X

FDA 510(k) clearance K033109 for ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS, Substantially Equivalent on 2004-03-23. Applicant: Scient'X.

Clearance details

Applicant: Scient'X
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2003-09-30
Decision date: 2004-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.