FDA 510(k)

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate

Número K: K213489 · 2022-01-27

Data da decisão2022-01-27

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate 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 2022-01-27 under 510(k) number K213489. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate?

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K213489.

When did Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate receive FDA 510(k) clearance?

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate received FDA 510(k) clearance on 2022-01-27, under 510(k) number K213489.

Who is the listed applicant for Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate?

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: 3.0mm Screws and 7-Hole Straight Fibula Plate?

The FDA product code for Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate is HRS.

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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 K203467WishBone Medical Plate and Screw System K193368Smart Correction System K180736WishBone Medical Plate and Screw System

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Fonte oficial

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