VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS— 510(k) K062666

Substantially Equivalent

Ortho Development Corp.

FDA 510(k) clearance K062666 for VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS, Substantially Equivalent on 2007-01-25. Applicant: Ortho Development Corp..

Clearance details

Applicant
Ortho Development Corp.
Product code
Code MQP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Draper, UT, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MQP

product code MQP
Injury
372
Malfunction
519
Total
891

Source: openFDA MAUDE database, through . 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.