U2 HIP STEM, TI PLASMA SPRAY— 510(k) K062978

Substantially Equivalent

United Orthopedic Corp.

FDA 510(k) clearance K062978 for U2 HIP STEM, TI PLASMA SPRAY, Substantially Equivalent on 2007-01-16. Applicant: United Orthopedic Corp..

Clearance details

Applicant: United Orthopedic Corp.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 2006-09-29
Decision date: 2007-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.