FIREBIRD SPINAL FIXATION SYSTEM— 510(k) K130176

Substantially Equivalent

Orthofix

FDA 510(k) clearance K130176 for FIREBIRD SPINAL FIXATION SYSTEM, Substantially Equivalent on 2013-03-28. Applicant: Orthofix.

Clearance details

Applicant: Orthofix
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2013-01-25
Decision date: 2013-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Lewisville, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.