VerteLP Interbody Fusion Device— 510(k) K151312

Substantially Equivalent

Vgi, LLC

FDA 510(k) clearance K151312 for VerteLP Interbody Fusion Device, Substantially Equivalent on 2016-01-13. Applicant: Vgi, LLC.

Clearance details

Applicant
Vgi, LLC
Product code
Code OVD
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Petersburg, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OVD

product code OVD
Death
5
Injury
495
Total
500

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.