ADVANCE UNICONDYLAR KNEE SYSTEM— 510(k) K014171

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K014171 for ADVANCE UNICONDYLAR KNEE SYSTEM, Substantially Equivalent on 2002-03-15. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant
Wrightmedicaltechnologyinc
Product code
Code HRY
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 HRY

product code HRY
Injury
1,551
Malfunction
2,753
Total
4,304

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.