DeviceClearance

K012334

Substantially Equivalent

CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116

Applicant
Bionx Implants, Inc.
Product code
MAI
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Tampere, FI
Download summary PDF View on FDA.gov ↗

Adverse events under product code MAI

product code MAI
Injury
1,948
Malfunction
8,580
Total
10,528

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.