NuVasive CoRoent Small Ti-C System— 510(k) K162138

Substantially Equivalent

Nu Vasive, Incorporated

FDA 510(k) clearance K162138 for NuVasive CoRoent Small Ti-C System, Substantially Equivalent on 2016-10-26. Applicant: Nu Vasive, Incorporated.

Clearance details

Applicant: Nu Vasive, Incorporated
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2016-08-01
Decision date: 2016-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.