DeviceClearance

K811017

Substantially Equivalent

HUCKSTEP INTRAMEDULLARY NAIL

Applicant
Downs Surgical , Ltd.
Product code
KTT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

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.