SpineFab Vertebral Body Replacement (VBR) System— 510(k) K142005

Substantially Equivalent

Oxford Performance Materials

FDA 510(k) clearance K142005 for SpineFab Vertebral Body Replacement (VBR) System, Substantially Equivalent on 2015-07-10. Applicant: Oxford Performance Materials.

Clearance details

Applicant: Oxford Performance Materials
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2014-07-23
Decision date: 2015-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Windsor, CT, 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.