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FDA 510(k)

LINEAR HIP STEM, SIZE 5

K-Number: K120241 · 2012-02-24

ApplicantEncore Medical L.P.
Decision Date2012-02-24
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINEAR HIP STEM, SIZE 5 is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2012-02-24 under 510(k) number K120241. 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 LINEAR HIP STEM, SIZE 5?

LINEAR HIP STEM, SIZE 5 is a medical device that received FDA 510(k) clearance on 2012-02-24. The listed applicant is Encore Medical L.P.. The 510(k) number is K120241.

When did LINEAR HIP STEM, SIZE 5 receive FDA 510(k) clearance?

LINEAR HIP STEM, SIZE 5 received FDA 510(k) clearance on 2012-02-24, under 510(k) number K120241.

Who is the listed applicant for LINEAR HIP STEM, SIZE 5?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINEAR HIP STEM, SIZE 5?

The FDA product code for LINEAR HIP STEM, SIZE 5 is LPH.

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Related Devices (Code: LPH)

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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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