K920621

Substantially Equivalent

ACUFEX PASSING PINS AND SURGICAL WIRE

Applicant
Acufex Microsurgical, Inc.
Product code
HWQ
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Great Neck, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HWQ

product code HWQ
Injury
137
Malfunction
443
Total
580

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.