U-MOTION II PS+ CUP— 510(k) K132455

Substantially Equivalent

United Orthopedic Corp.

FDA 510(k) clearance K132455 for U-MOTION II PS+ CUP, Substantially Equivalent on 2013-09-03. Applicant: United Orthopedic Corp..

Clearance details

Applicant: United Orthopedic Corp.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2013-08-06
Decision date: 2013-09-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.