FDA 510(k)

Stryker Orthopaedics Hip Systems Labeling Update

Número K: K153345 · 2016-05-25

Data da decisão2016-05-25

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stryker Orthopaedics Hip Systems Labeling Update is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K153345. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Stryker Orthopaedics Hip Systems Labeling Update?

Stryker Orthopaedics Hip Systems Labeling Update is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Stryker Orthopaedics. The 510(k) number is K153345.

When did Stryker Orthopaedics Hip Systems Labeling Update receive FDA 510(k) clearance?

Stryker Orthopaedics Hip Systems Labeling Update received FDA 510(k) clearance on 2016-05-25, under 510(k) number K153345.

Who is the listed applicant for Stryker Orthopaedics Hip Systems Labeling Update?

The FDA 510(k) record lists Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker Orthopaedics Hip Systems Labeling Update?

The FDA product code for Stryker Orthopaedics Hip Systems Labeling Update is LPH.

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Outros registros que listam Stryker Orthopaedics como candidato(a)

K211703Insignia Hip Stem K191414EXETER Centralizer, EXETER 2.5mm Plug K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads K173849Triathlon Total Knee System K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

Dispositivos Relacionados (Código: 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.

Fonte oficial

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