STALIF TT— 510(k) K041617

Substantially Equivalent

Surgicraft , Ltd.

FDA 510(k) clearance K041617 for STALIF TT, Substantially Equivalent on 2004-09-08. Applicant: Surgicraft , Ltd..

Clearance details

Applicant
Surgicraft , Ltd.
Product code
Code MQP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chicago, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MQP

product code MQP
Injury
372
Malfunction
519
Total
891

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.