FDA 510(k)

Craniomaxillofacial Distraction System (CMFD)

Número K: K162594 · 2017-05-08

Data da decisão2017-05-08

Código do produtoMQN

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Craniomaxillofacial Distraction System (CMFD) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA Products, LLC. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K162594. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Craniomaxillofacial Distraction System (CMFD)?

Craniomaxillofacial Distraction System (CMFD) is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Synthes USA Products, LLC. The 510(k) number is K162594.

When did Craniomaxillofacial Distraction System (CMFD) receive FDA 510(k) clearance?

Craniomaxillofacial Distraction System (CMFD) received FDA 510(k) clearance on 2017-05-08, under 510(k) number K162594.

Who is the listed applicant for Craniomaxillofacial Distraction System (CMFD)?

The FDA 510(k) record lists Synthes USA Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Craniomaxillofacial Distraction System (CMFD)?

The FDA product code for Craniomaxillofacial Distraction System (CMFD) is MQN.

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