Cervical Stand Alone System— 510(k) K161280

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K161280 for Cervical Stand Alone System, Substantially Equivalent on 2016-06-17. Applicant: Orthofix, Inc..

Clearance details

Applicant: Orthofix, Inc.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2016-05-06
Decision date: 2016-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Lewisville, TX, US

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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.