FDA 510(k)

Restoration® Modular Hip System

Número K: K193233 · 2020-05-27

RequerenteHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)

Data da decisão2020-05-27

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Restoration® Modular Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K193233. 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 Restoration® Modular Hip System?

Restoration® Modular Hip System is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). The 510(k) number is K193233.

When did Restoration® Modular Hip System receive FDA 510(k) clearance?

Restoration® Modular Hip System received FDA 510(k) clearance on 2020-05-27, under 510(k) number K193233.

Who is the listed applicant for Restoration® Modular Hip System?

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

What is the FDA product code for Restoration® Modular Hip System?

The FDA product code for Restoration® Modular Hip System is LPH.

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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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