FDA 510(k)

Responsive Orthopedics Total Hip Arthroplasty System

Numéro K : K163585 · 2017-06-02

Date de décision2017-06-02

Code produitLZO

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Responsive Orthopedics Total Hip Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Orthopedics, LLC. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K163585. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Responsive Orthopedics Total Hip Arthroplasty System?

Responsive Orthopedics Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Responsive Orthopedics, LLC. The 510(k) number is K163585.

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

Responsive Orthopedics Total Hip Arthroplasty System received FDA 510(k) clearance on 2017-06-02, under 510(k) number K163585.

Who is the listed applicant for Responsive Orthopedics Total Hip Arthroplasty System?

The FDA 510(k) record lists Responsive Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Responsive Orthopedics Total Hip Arthroplasty System is LZO.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : LZO)

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG K260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

Source officielle

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