NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System— 510(k) K193506

Substantially Equivalent

Nu Vasive, Incorporated

FDA 510(k) clearance K193506 for NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System, Substantially Equivalent on 2020-02-26. Applicant: Nu Vasive, Incorporated.

Clearance details

Applicant: Nu Vasive, Incorporated
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2019-12-18
Decision date: 2020-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.