FDA 510(k)

NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System

Номер K: K163425 · 2017-03-24

Дата решения2017-03-24

Код продуктаHRS

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Narang Medical USA Corporation. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K163425. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System?

NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Narang Medical USA Corporation. The 510(k) number is K163425.

When did NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System receive FDA 510(k) clearance?

NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System received FDA 510(k) clearance on 2017-03-24, under 510(k) number K163425.

Who is the listed applicant for NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System?

The FDA 510(k) record lists Narang Medical USA Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System?

The FDA product code for NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System is HRS.

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: HRS)

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

Официальный источник

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