UC-PLUS SOLUTION UNICONDYLAR KNEE— 510(k) K032052

Substantially Equivalent

Plus Orthopedics

FDA 510(k) clearance K032052 for UC-PLUS SOLUTION UNICONDYLAR KNEE, Substantially Equivalent on 2003-07-25. Applicant: Plus Orthopedics.

Clearance details

Applicant: Plus Orthopedics
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 2003-07-02
Decision date: 2003-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, US

Download summary PDF View 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, 2020-01-01 through 2026-04-23. 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.