DeviceClearance

K935391

Substantially Equivalent

SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK

Applicant
3M Health Care, Sarns
Product code
GFA
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GFA

product code GFA
Death
2
Injury
140
Malfunction
2,337
Total
2,479

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.