CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM— 510(k) K120570

Substantially Equivalent

Choicespine, LP

FDA 510(k) clearance K120570 for CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM, Substantially Equivalent on 2012-04-05. Applicant: Choicespine, LP.

Clearance details

Applicant
Choicespine, LP
Product code
Code MQP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Knoxville, TN, 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.