DeviceClearance

K122635

Substantially Equivalent

TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR

Applicant
Tornier, Inc.
Product code
MAI
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bloomington, MN, US
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.