FDA 510(k)

KEYSTONE PEEK Cage System

Número K: K211689 · 2021-09-21

RequerenteShanghai Sanyou Medical Co, Ltd.

Data da decisão2021-09-21

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

KEYSTONE 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 2021-09-21 under 510(k) number K211689. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KEYSTONE PEEK Cage System?

KEYSTONE PEEK Cage System is a medical device that received FDA 510(k) clearance on 2021-09-21. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K211689.

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

KEYSTONE PEEK Cage System received FDA 510(k) clearance on 2021-09-21, under 510(k) number K211689.

Who is the listed applicant for KEYSTONE 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 KEYSTONE PEEK Cage System?

The FDA product code for KEYSTONE PEEK Cage System is MAX.

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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 K212066Sistema Adena-Zina K163366Shanghai Sanyou CARMEN Cervical Fusion System K163422Shanghai Sanyou PEEK Cage System

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Fonte oficial

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