Velofix(tm) Interbody Fusion System— 510(k) K171749

Substantially Equivalent

U&I Corporation

FDA 510(k) clearance K171749 for Velofix(tm) Interbody Fusion System, Substantially Equivalent on 2017-07-13. Applicant: U&I Corporation.

Clearance details

Applicant: U&I Corporation
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2017-06-13
Decision date: 2017-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uijeongbu-Si, Gyeonggi-Do, KR

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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.