FDA 510(k)

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath

Número K: K230874 · 2023-05-23

Data da decisão2023-05-23

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Endophix Co., Ltd.. It received FDA 510(k) clearance on 2023-05-23 under 510(k) number K230874. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath?

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath is a medical device that received FDA 510(k) clearance on 2023-05-23. The listed applicant is Suzhou Endophix Co., Ltd.. The 510(k) number is K230874.

When did Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath receive FDA 510(k) clearance?

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath received FDA 510(k) clearance on 2023-05-23, under 510(k) number K230874.

Who is the listed applicant for Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath?

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

What is the FDA product code for Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath?

The FDA product code for Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath is MBI.

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Fonte oficial

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