FDA 510(k) Applications Submitted by Suzhou Endophix Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K231002 04/07/2023 Javelot 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) Suzhou Endophix Co., Ltd.
K230874 03/30/2023 Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath Suzhou Endophix Co., Ltd.
K232725 09/06/2023 Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor Suzhou Endophix Co., Ltd.
K232941 09/20/2023 Megaloop Button System Suzhou Endophix Co., Ltd.


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