FDA 510(k)

UTF STEM-REDUCED, ADDITIONAL SIZES

K-Number: K132207 · 2013-08-30

Decision Date2013-08-30

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

UTF STEM-REDUCED, ADDITIONAL SIZES 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 2013-08-30 under 510(k) number K132207. 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, ADDITIONAL SIZES?

UTF STEM-REDUCED, ADDITIONAL SIZES is a medical device that received FDA 510(k) clearance on 2013-08-30. The listed applicant is United Orthopedic Corporation. The 510(k) number is K132207.

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

UTF STEM-REDUCED, ADDITIONAL SIZES received FDA 510(k) clearance on 2013-08-30, under 510(k) number K132207.

Who is the listed applicant for UTF STEM-REDUCED, ADDITIONAL SIZES?

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, ADDITIONAL SIZES?

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

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Other records listing United Orthopedic Corporation as applicant

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Related Devices (Code: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 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 Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.

Official Source

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