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FDA 510(k)

U2 Femoral Head

K-Number: K162957 · 2017-07-17

ApplicantUnited Orthopedic Corporation
Decision Date2017-07-17
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U2 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 2017-07-17 under 510(k) number K162957. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U2 Femoral Head?

U2 Femoral Head is a medical device that received FDA 510(k) clearance on 2017-07-17. The listed applicant is United Orthopedic Corporation. The 510(k) number is K162957.

When did U2 Femoral Head receive FDA 510(k) clearance?

U2 Femoral Head received FDA 510(k) clearance on 2017-07-17, under 510(k) number K162957.

Who is the listed applicant for U2 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 Femoral Head?

The FDA product code for U2 Femoral Head is LPH.

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: LPH)

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.

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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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