NUVASIVE COROENT NO-PROFILE SYSTEM— 510(k) K112561

Substantially Equivalent

Nuvasive, Inc.

FDA 510(k) clearance K112561 for NUVASIVE COROENT NO-PROFILE SYSTEM, Substantially Equivalent on 2012-03-13. Applicant: Nuvasive, Inc..

Clearance details

Applicant: Nuvasive, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2011-09-02
Decision date: 2012-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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.