K161360

Substantially Equivalent

U2 Total Knee System, PSA Tibial Insert

Applicant: United Orthopedic Corporation
Product code: JWH
Advisory panel: Orthopedic
Date received: 2016-05-16
Decision date: 2017-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.