FDA 510(k)

iNSitu Total Hip System

Número K: K172501 · 2017-09-21

Data da decisão2017-09-21

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

iNSitu Total Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Theken Companies, LLC. It received FDA 510(k) clearance on 2017-09-21 under 510(k) number K172501. 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 iNSitu Total Hip System?

iNSitu Total Hip System is a medical device that received FDA 510(k) clearance on 2017-09-21. The listed applicant is Theken Companies, LLC. The 510(k) number is K172501.

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

iNSitu Total Hip System received FDA 510(k) clearance on 2017-09-21, under 510(k) number K172501.

Who is the listed applicant for iNSitu Total Hip System?

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

What is the FDA product code for iNSitu Total Hip System?

The FDA product code for iNSitu Total 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 Theken Companies, LLC como candidato(a)

K191297iNSitu Bipolar Hip System K192071iNSitu Total Hip System K161184iNSitu Total Hip System

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.