E-XPE Acetabular Components and U-Motion II Acetabular Cup— 510(k) K172833

Name: FDA 510(k) clearance K172833
Creator: U.S. Food and Drug Administration
Published: 2018-06-12

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K172833 for E-XPE Acetabular Components and U-Motion II Acetabular Cup, Substantially Equivalent on 2018-06-12. Applicant: United Orthopedic Corporation. Device class: 2.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code OQI
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2017-09-19
Decision date: 2018-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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