K861822

Substantially Equivalent

MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI

Applicant
Valley Forge Scientific Corp.
Product code
GWO
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Valley Forge, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GWO

product code GWO
Malfunction
583
Total
583

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.