FDA 510(k)

7D FlashLock 1 Cirúrgico, Conector de Borracha Flexível Cirúrgico - 5,5 mm - 150 mm, 7D Flex Array

Número K: K201966 · 2020-09-03

Data da decisão2020-09-03

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical, Inc.. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K201966. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array?

7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is 7D Surgical, Inc.. The 510(k) number is K201966.

When did 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array receive FDA 510(k) clearance?

7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array received FDA 510(k) clearance on 2020-09-03, under 510(k) number K201966.

Who is the listed applicant for 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array?

The FDA 510(k) record lists 7D Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array?

The FDA product code for 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array is OLO.

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Outros registros que listam 7D Surgical, Inc. como candidato(a)

K210457Quadro de Registo 7D, Conector de Pin de Piso Iliaco Flexível 7D, Bloco de Guia de Pin 7D, Pin de Steinmann de 3,2 mm 7D, Parafuso e Chave de Cimeira Iliaca 7D K210555Sistema Cirúrgico 7D - Guia de Broca K192945Aplicação de Biópsia Craniana e Colocação de Cateter Ventricular do Sistema Cirúrgico 7D K192140Sistema Cirúrgico 7D K183276Sistema Cirúrgico 7D K181041Aplicação Craniana do Sistema Cirúrgico 7D

Ver todos os 9 dispositivos →

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