VAULT-C INTERVERTEBRAL BODY FUSION DEVICE— 510(k) K132029

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K132029 for VAULT-C INTERVERTEBRAL BODY FUSION DEVICE, Substantially Equivalent on 2013-11-25. Applicant: Spinal USA.

Clearance details

Applicant: Spinal USA
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2013-07-01
Decision date: 2013-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.