FDA 510(k)

Materialise TKA Guide System

Número K: K221337 · 2022-07-05

Data da decisão2022-07-05

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Materialise TKA Guide System is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2022-07-05 under 510(k) number K221337. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Materialise TKA Guide System?

Materialise TKA Guide System is a medical device that received FDA 510(k) clearance on 2022-07-05. The listed applicant is Materialise NV. The 510(k) number is K221337.

When did Materialise TKA Guide System receive FDA 510(k) clearance?

Materialise TKA Guide System received FDA 510(k) clearance on 2022-07-05, under 510(k) number K221337.

Who is the listed applicant for Materialise TKA Guide System?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Materialise TKA Guide System?

The FDA product code for Materialise TKA Guide System is JWH.

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Outros registros que listam Materialise NV como candidato(a)

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K251964Mimics Thoracic Planner K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models K253793Materialise TKA Guide System K251554Materialise TKA Guide System K243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

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Fonte oficial

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