FDA 510(k)

Shanghai Sanyou PEEK Cage System

Número K: K163422 · 2017-09-18

RequerenteShanghai Sanyou Medical Co, Ltd.

Data da decisão2017-09-18

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Shanghai Sanyou PEEK Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2017-09-18 under 510(k) number K163422. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Shanghai Sanyou PEEK Cage System?

Shanghai Sanyou PEEK Cage System is a medical device that received FDA 510(k) clearance on 2017-09-18. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K163422.

When did Shanghai Sanyou PEEK Cage System receive FDA 510(k) clearance?

Shanghai Sanyou PEEK Cage System received FDA 510(k) clearance on 2017-09-18, under 510(k) number K163422.

Who is the listed applicant for Shanghai Sanyou PEEK Cage System?

The FDA 510(k) record lists Shanghai Sanyou Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shanghai Sanyou PEEK Cage System?

The FDA product code for Shanghai Sanyou PEEK Cage System is ODP.

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Outros registros que listam Shanghai Sanyou Medical Co, Ltd. como candidato(a)

K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System K230961Zeus Spinal System K231931Sistema Espinal Adena-Zina K211689KEYSTONE PEEK Cage System K212066Sistema Adena-Zina K163366Shanghai Sanyou CARMEN Cervical Fusion System

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Fonte oficial

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