FDA 510(k)

Medtronic Total Hip Arthroplasty System

Número K: K183129 · 2019-07-26

Data da decisão2019-07-26

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medtronic Total Hip Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K183129. 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 Medtronic Total Hip Arthroplasty System?

Medtronic Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K183129.

When did Medtronic Total Hip Arthroplasty System receive FDA 510(k) clearance?

Medtronic Total Hip Arthroplasty System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K183129.

Who is the listed applicant for Medtronic Total Hip Arthroplasty System?

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

What is the FDA product code for Medtronic Total Hip Arthroplasty System?

The FDA product code for Medtronic Total Hip Arthroplasty System is LPH.

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Outros registros que listam Medtronic Advanced Energy como candidato(a)

K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0 K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini K170610PlasmaBlade T K170296CoreCath 2.7S K152703PlasmaBlade TnA Tonsil and Adenoid Dissection Device

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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