K130445

Substantially Equivalent

VAULT ALIF SYSTEM

Applicant: Spinal USA
Product code: OVD
Advisory panel: Orthopedic
Date received: 2013-02-21
Decision date: 2013-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, US

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.