NEXUS II FEMORAL COMPONENT— 510(k) K954262

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K954262 for NEXUS II FEMORAL COMPONENT, Substantially Equivalent on 1995-11-03. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant
Wrightmedicaltechnologyinc
Product code
Code JDI
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arlington, TN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JDI

product code JDI
Death
65
Injury
12,943
Malfunction
1,681
Total
14,689

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.