K022563

Substantially Equivalent

HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1

Applicant
Implex Corp.
Product code
MQP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Allendale, NJ, US
Download summary PDF View 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.