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510(k) K172833

Device
E-XPE Acetabular Components And U-Motion II Acetabular Cup
Applicant
United Orthopedic Corporation
510(k) number
K172833
Product code
OQI  
Decision
Substantially Equivalent (SESE)
Decision date
2018-06-12
Date received
2017-09-19
Regulation
888.3353
Classification name
Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gimpel Chien
Address
No 57, Park Ave. 2, Science Park Hsinchu TW 300 300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OQI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252451EPORE® XO cup systemImplantcast GmbH2026-04-24
K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.2020-10-29
K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.2018-03-12
K111481CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERSCorin USA2012-02-06

Legacy Summary#

summary

FDA Review#

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