510(k) K180498— NuVasive Reline Fenestrated Screws, High V+ Bone Cement

Substantially Equivalent

Nu Vasive, Incorporated

Clearance details

Applicant: Nu Vasive, Incorporated
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2018-02-26
Decision date: 2018-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Adverse events under product code PML

product code PML

Death: 8
Total: 8

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.