DeviceClearance

K081700

Substantially Equivalent

SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION

Applicant
Synthes (Usa)
Product code
HWC
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
West Chester, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC
Death
20
Injury
15,910
Malfunction
8,192
Other
1
Total
24,123

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.