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FDA 510(k)

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath

K-Number: K230874 · 2023-05-23

ApplicantSuzhou Endophix Co., Ltd.
Decision Date2023-05-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Suzhou Endophix Co., Ltd.. The 510(k) number is K230874.

When was Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath approved by the FDA?

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

What company makes Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath?

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath is manufactured by Suzhou Endophix Co., Ltd..

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.

Other Devices by Suzhou Endophix Co., Ltd.

K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) K232941Megaloop Button System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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