UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM— 510(k) K982859

Substantially Equivalent

Plus Orthopedics

FDA 510(k) clearance K982859 for UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM, Substantially Equivalent on 1999-07-30. Applicant: Plus Orthopedics.

Clearance details

Applicant
Plus Orthopedics
Product code
Code HRY
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, 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.