FDA 510(k)

FitRite™ Total Hip Arthroplasty System

Номер K: K153057 · 2016-06-23

Дата решения2016-06-23

Код продуктаJDI

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

FitRite™ Total Hip Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Excera Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153057. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the FitRite™ Total Hip Arthroplasty System?

FitRite™ Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Excera Orthopedics, Inc.. The 510(k) number is K153057.

When did FitRite™ Total Hip Arthroplasty System receive FDA 510(k) clearance?

FitRite™ Total Hip Arthroplasty System received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153057.

Who is the listed applicant for FitRite™ Total Hip Arthroplasty System?

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

What is the FDA product code for FitRite™ Total Hip Arthroplasty System?

The FDA product code for FitRite™ Total Hip Arthroplasty System is JDI.

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.

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Связанные устройства (Код: JDI)

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetабулярные подкладки; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Официальный источник

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