FDA 510(k)

iNSitu Total Hip System

Номер K: K191936 · 2019-08-20

Дата решения2019-08-20

Код продуктаLPH

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

iNSitu Total Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Thecken Companies, LLC. It received FDA 510(k) clearance on 2019-08-20 under 510(k) number K191936. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the iNSitu Total Hip System?

iNSitu Total Hip System is a medical device that received FDA 510(k) clearance on 2019-08-20. The listed applicant is Thecken Companies, LLC. The 510(k) number is K191936.

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

iNSitu Total Hip System received FDA 510(k) clearance on 2019-08-20, under 510(k) number K191936.

Who is the listed applicant for iNSitu Total Hip System?

The FDA 510(k) record lists Thecken 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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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

Связанные устройства (Код: 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.

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.