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FDA 510(k)

UTF STEM, REDUCED

K-Number: K123550 · 2013-05-01

ApplicantUnited Orthopedic Corporation
Decision Date2013-05-01
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UTF STEM, REDUCED 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 2013-05-01 under 510(k) number K123550. 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 UTF STEM, REDUCED?

UTF STEM, REDUCED is a medical device that received FDA 510(k) clearance on 2013-05-01. The listed applicant is United Orthopedic Corporation. The 510(k) number is K123550.

When did UTF STEM, REDUCED receive FDA 510(k) clearance?

UTF STEM, REDUCED received FDA 510(k) clearance on 2013-05-01, under 510(k) number K123550.

Who is the listed applicant for UTF STEM, REDUCED?

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 UTF STEM, REDUCED?

The FDA product code for UTF STEM, REDUCED is LPH.

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Other records listing United Orthopedic Corporation as applicant

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K253948Momentum Acetabular Cup SystemK252725Stem 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, #0

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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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.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.

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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