UNITED STEM, PSA TYPE— 510(k) K100981

Substantially Equivalent

United Orthopedic Corp.

FDA 510(k) clearance K100981 for UNITED STEM, PSA TYPE, Substantially Equivalent on 2010-06-14. Applicant: United Orthopedic Corp..

Clearance details

Applicant: United Orthopedic Corp.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2010-04-09
Decision date: 2010-06-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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.