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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 the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2018-06-12 under 510(k) 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. The listed applicant is United Orthopedic Corporation. The 510(k) number is K172833.

When did E-XPE Acetabular Components and U-Motion II Acetabular Cup receive FDA 510(k) clearance?

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

Who is the listed applicant for E-XPE Acetabular Components and U-Motion II Acetabular Cup?

The FDA 510(k) record lists United Orthopedic Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing United Orthopedic Corporation as applicant

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Related Devices (Code: OQI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252451EPORE® XO cup systemImplantcast GmbHK192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.

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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