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FDA 510(k)

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor

K-Number: K232725 · 2023-11-02

ApplicantSuzhou Endophix Co., Ltd.
Decision Date2023-11-02
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor is a medical device manufactured by Suzhou Endophix Co., Ltd.. It received FDA 510(k) clearance on 2023-11-02 under approval number K232725. 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 Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-11-02. It is manufactured by Suzhou Endophix Co., Ltd.. The 510(k) number is K232725.

When was Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor approved by the FDA?

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor received FDA 510(k) clearance on 2023-11-02, under approval number K232725.

What company makes Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor is manufactured by Suzhou Endophix Co., Ltd..

What is the FDA product code for Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

The FDA product code for Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor is MBI.

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Suzhou Endophix Co., Ltd.

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) K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath K232941Megaloop Button System

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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