SPINAL USA VBR SYSTEM— 510(k) K061752

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K061752 for SPINAL USA VBR SYSTEM, Substantially Equivalent on 2006-08-15. Applicant: Spinal USA.

Clearance details

Applicant
Spinal USA
Product code
Code MQP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Flowood, MS, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MQP

product code MQP
Injury
372
Malfunction
519
Total
891

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.