FDA 510(k)

Klassic HD Hip System

Número K: K161073 · 2016-10-19

Data da decisão2016-10-19

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Klassic HD Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K161073. 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 Klassic HD Hip System?

Klassic HD Hip System is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K161073.

When did Klassic HD Hip System receive FDA 510(k) clearance?

Klassic HD Hip System received FDA 510(k) clearance on 2016-10-19, under 510(k) number K161073.

Who is the listed applicant for Klassic HD Hip System?

The FDA 510(k) record lists Total Joint Othopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klassic HD Hip System?

The FDA product code for Klassic HD Hip System is LPH.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Total Joint Othopedics, Inc. como candidato(a)

K243991Klassic Knee System - Revision Tibial Baseplate K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post K230537Klassic Knee Revision System K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm comprimento da cabeça K191399BIOLOX CONTOURA Ceramic Femoral Head K171962Klassic HD® Hip System

Ver todos os 7 dispositivos →

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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.