BRIGADE STANDALONE SYSTEM— 510(k) K123045

Substantially Equivalent

Nuvasive, Inc.

FDA 510(k) clearance K123045 for BRIGADE STANDALONE SYSTEM, Substantially Equivalent on 2013-04-16. Applicant: Nuvasive, Inc..

Clearance details

Applicant: Nuvasive, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2012-10-01
Decision date: 2013-04-16
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.