FDA 510(k)

Trident® II Acetabular System

Numéro K : K171768 · 2017-10-02

DemandeurHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Date de décision2017-10-02

Code produitLPH

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Trident® II Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K171768. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Trident® II Acetabular System?

Trident® II Acetabular System is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K171768.

When did Trident® II Acetabular System receive FDA 510(k) clearance?

Trident® II Acetabular System received FDA 510(k) clearance on 2017-10-02, under 510(k) number K171768.

Who is the listed applicant for Trident® II Acetabular System?

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

What is the FDA product code for Trident® II Acetabular System?

The FDA product code for Trident® II Acetabular System is LPH.

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.

NCT07608549Étude pilote de phase 1 sur la sécurité du FLASHNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Système d'évaluation du cathéter Uro-Cam assisté par intelligence artificielle pour le diagnostic du cancer de la vessieNOT_YET_RECRUITING

Autres dossiers indiquant Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics en tant que demandeur

K233261Système de Remplacement Modulaire Global K210893Restoration Anatomic Shell K203099Triathlon PKR System K191358Trident II Acetabular System K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

Voir tous les 9 dispositifs →

Dispositifs connexes (Code : LPH)

K261453G7® Système acetabulaireZimmer 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.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.