FDA 510(k)

WishBone Medical Plate and Screw System

Número K: K203467 · 2020-12-23

Data da decisão2020-12-23

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

WishBone Medical Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K203467. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WishBone Medical Plate and Screw System?

WishBone Medical Plate and Screw System is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K203467.

When did WishBone Medical Plate and Screw System receive FDA 510(k) clearance?

WishBone Medical Plate and Screw System received FDA 510(k) clearance on 2020-12-23, under 510(k) number K203467.

Who is the listed applicant for WishBone Medical Plate and Screw System?

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

What is the FDA product code for WishBone Medical Plate and Screw System?

The FDA product code for WishBone Medical Plate and Screw System is HWC. This falls under the Cardiovascular category.

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Outros registros que listam Wishbone Medical, Inc. como candidato(a)

K231461Smart Correction System (HA Half Pins)K230527WishBone Medical Plate and Screw System K221366Smart Correction System Rings and Compatible HA-Coated Half Pins K213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate K193368Smart Correction System K180736WishBone Medical Plate and Screw System

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Fonte oficial

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