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

Name: FDA 510(k) clearance K162138
Creator: U.S. Food and Drug Administration
Published: 2016-10-26

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. Device class: 2.

Clearance details

Applicant: Nu Vasive, Incorporated
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

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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.