UNICOMPARTMENTAL KNEE— 510(k) K072704

Substantially Equivalent

Valpo Orthopedic Technology, Inc.

FDA 510(k) clearance K072704 for UNICOMPARTMENTAL KNEE, Substantially Equivalent on 2008-02-19. Applicant: Valpo Orthopedic Technology, Inc..

Clearance details

Applicant
Valpo Orthopedic Technology, Inc.
Product code
Code HRY
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, 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.