INTERFUSE T INVERTEBRAL BODY FUSION DEVICE— 510(k) K110226

Substantially Equivalent

Vertebral Technologies, Inc.

FDA 510(k) clearance K110226 for INTERFUSE T INVERTEBRAL BODY FUSION DEVICE, Substantially Equivalent on 2011-05-27. Applicant: Vertebral Technologies, Inc..

Clearance details

Applicant
Vertebral Technologies, Inc.
Product code
Code MAX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Minneapolis, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MAX

product code MAX
Death
13
Injury
1,305
Malfunction
2,885
Total
4,203

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.