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FDA 510(k)

U2 Bipolar Implant and 22mm Femoral Head

K-Number: K152439 · 2016-04-07

ApplicantUnited Orthopedic Corporation
Decision Date2016-04-07
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U2 Bipolar Implant and 22mm Femoral Head 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 2016-04-07 under 510(k) number K152439. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U2 Bipolar Implant and 22mm Femoral Head?

U2 Bipolar Implant and 22mm Femoral Head is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is United Orthopedic Corporation. The 510(k) number is K152439.

When did U2 Bipolar Implant and 22mm Femoral Head receive FDA 510(k) clearance?

U2 Bipolar Implant and 22mm Femoral Head received FDA 510(k) clearance on 2016-04-07, under 510(k) number K152439.

Who is the listed applicant for U2 Bipolar Implant and 22mm Femoral Head?

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 U2 Bipolar Implant and 22mm Femoral Head?

The FDA product code for U2 Bipolar Implant and 22mm Femoral Head is KWY.

Related Clinical Trials

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Other records listing United Orthopedic Corporation as applicant

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.

K252725Stem Extension Line (U2 Total Knee System—PSA Type)K252303Stem Extension Line (USTAR II System)K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaK242315Resolve Modular Revision Hip StemK243466Conformity Stem Extension Line, #0K243024Cellbrick Knee Spacer

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Related Devices (Code: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical 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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