Velofix Interbody Fusion System— 510(k) K190067

Substantially Equivalent

U&I Corporation

FDA 510(k) clearance K190067 for Velofix Interbody Fusion System, Substantially Equivalent on 2019-02-04. Applicant: U&I Corporation.

Clearance details

Applicant: U&I Corporation
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2019-01-15
Decision date: 2019-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Uijeongbu-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.