DeviceClearance

K051245

Substantially Equivalent

POLYFORM SYNTHETIC MESH

Applicant
Proxy Biomedical , Ltd.
Product code
OTO
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stillwater, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OTO

product code OTO
Injury
840
Total
840

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.