DeviceClearance

K132698

Substantially Equivalent

FASTOUCH FIXATION SYSTEM

Applicant
Via Surgical , Ltd.
Product code
GDW
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Providence, RI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GDW

product code GDW
Death
450
Injury
12,684
Malfunction
68,730
Other
6
Total
81,870

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.