FDA 510(k)

OsteoCentric Integrated Hip Fastener System

Номер K: K210247 · 2021-04-30

ЗаявительOsteocentric Technologies D.B.A. Osteocentric Trauma

Дата решения2021-04-30

Код продуктаJDO

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

OsteoCentric Integrated Hip Fastener System is the device name listed in this FDA 510(k) record. The listed applicant is Osteocentric Technologies D.B.A. Osteocentric Trauma. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K210247. The device is classified under product code JDO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the OsteoCentric Integrated Hip Fastener System?

OsteoCentric Integrated Hip Fastener System is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Osteocentric Technologies D.B.A. Osteocentric Trauma. The 510(k) number is K210247.

When did OsteoCentric Integrated Hip Fastener System receive FDA 510(k) clearance?

OsteoCentric Integrated Hip Fastener System received FDA 510(k) clearance on 2021-04-30, under 510(k) number K210247.

Who is the listed applicant for OsteoCentric Integrated Hip Fastener System?

The FDA 510(k) record lists Osteocentric Technologies D.B.A. Osteocentric Trauma as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoCentric Integrated Hip Fastener System?

The FDA product code for OsteoCentric Integrated Hip Fastener System is JDO.

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: JDO)

K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsSmith & Nephew, Inc.K193029CONQUEST FNSmith & Nephew, Inc.K173826THP Hip Fracture Plating SystemBiomet, Inc.K172785CONQUEST FNSmith & Nephew K152686CONQUEST FNSmith & Nephew

Официальный источник

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