FDA 510(k)

FlashLock 1 Quirúrgico 7D, Conector de Varilla Flexible Quirúrgico 7D - 5.5 mm - 150 mm, Flex Array Quirúrgico 7D

N.º K: K201966 · 2020-09-03

Fecha de decisión2020-09-03

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a 7D Surgical, Inc. como solicitante

K210457Marco de Registro 7D, Conector de Pin Iliaco Flex 7D, Bloque de Guía de Pin 7D, Pin Steinmann 3.2 mm 7D, Chuck y Llave de Cresta Iliaca 7D K210555Sistema Quirúrgico 7D - Guía de Taladro K192945Aplicación de Biopsia Craneal y Colocación de Catéter Ventricular del Sistema Quirúrgico 7D K192140Sistema Quirúrgico 7D K183276Sistema Quirúrgico 7D K181041Aplicación Craneal del Sistema Quirúrgico 7D

Ver todos los 9 dispositivos →

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Fuente oficial

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