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FDA 510(k)

E-XPE Acetabular Components and U-Motion II Acetabular Cup

K-Number: K172833 · 2018-06-12

ApplicantUnited Orthopedic Corporation
Decision Date2018-06-12
Product CodeOQI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

E-XPE Acetabular Components and U-Motion II Acetabular Cup is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2018-06-12 under approval number K172833. The device is classified under product code OQI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-XPE Acetabular Components and U-Motion II Acetabular Cup?

E-XPE Acetabular Components and U-Motion II Acetabular Cup is a medical device that received FDA 510(k) clearance on 2018-06-12. It is manufactured by United Orthopedic Corporation. The 510(k) number is K172833.

When was E-XPE Acetabular Components and U-Motion II Acetabular Cup approved by the FDA?

E-XPE Acetabular Components and U-Motion II Acetabular Cup received FDA 510(k) clearance on 2018-06-12, under approval number K172833.

What company makes E-XPE Acetabular Components and U-Motion II Acetabular Cup?

E-XPE Acetabular Components and U-Motion II Acetabular Cup is manufactured by United Orthopedic Corporation.

What is the FDA product code for E-XPE Acetabular Components and U-Motion II Acetabular Cup?

The FDA product code for E-XPE Acetabular Components and U-Motion II Acetabular Cup is OQI.

Related Clinical Trials

NCT04090359 Dual Mobility Acetabular Cups in Revision TJA RECRUITING NCT04389749 Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures RECRUITING

Other Devices by United Orthopedic Corporation

K152430All Poly Tibial Component K152439U2 Bipolar Implant and 22mm Femoral Head K152530UCP Stem K172251UTS Stem K170089U-Motion II Acetabular System— Additional sizes K163441Locking Cage, Full XPE Cup

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Related Devices (Code: OQI)

K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc. K252451EPORE® XO cup systemImplantcast GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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