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FDA Product Code

FDA Product Code OQI — Clearance Directory

Device Class
Class II
Assigned Panel
Orthopedic
21 CFR Citation
888.3353

510(k) Clearances — 5 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K252451 EPORE® XO cup system Implantcast GmbH 2026-04-24 Traditional PDF ↗
K192989 Libertas E-XLPE Modular Liner Maxx Orthopedics, Inc. 2020-10-29 Traditional PDF ↗
K172833 E-XPE Acetabular Components and U-Motion II Acetabular Cup United Orthopedic Corporation 2018-06-12 Traditional PDF ↗
K173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners Exactech, Inc. 2018-03-12 Traditional PDF ↗
K111481 CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS Corin USA 2012-02-06 Traditional PDF ↗

Product code OQI · Class II · Orthopedic. Data: openFDA.