SURGICAL DYNAMICS MESH CAGE SYSTEM— 510(k) K003709

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K003709 for SURGICAL DYNAMICS MESH CAGE SYSTEM, Substantially Equivalent on 2001-07-18. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant
United States Surgical, A Division of Tyco Healthc
Product code
Code MQP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norwalk, CT, 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.