USTAR II System— 510(k) K190100

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K190100 for USTAR II System, Substantially Equivalent on 2019-09-23. Applicant: United Orthopedic Corporation.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2019-01-22
Decision date: 2019-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.