COROENT SMALL INTERBODY SYSTEM— 510(k) K140921

Substantially Equivalent

Nu Vasive, Incorporated

FDA 510(k) clearance K140921 for COROENT SMALL INTERBODY SYSTEM, Substantially Equivalent on 2014-07-28. Applicant: Nu Vasive, Incorporated.

Clearance details

Applicant
Nu Vasive, Incorporated
Product code
Code ODP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ODP

product code ODP
Injury
310
Total
310

Source: openFDA MAUDE database, through . 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.