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