CERVICAL STAND ALONE SYSTEM— 510(k) K132999

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K132999 for CERVICAL STAND ALONE SYSTEM, Substantially Equivalent on 2014-04-14. Applicant: Orthofix, Inc..

Clearance details

Applicant: Orthofix, Inc.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2013-09-24
Decision date: 2014-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
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.