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FDA 510(k)

Fixone All Suture Anchor

K-Number: K192709 · 2020-12-15

ApplicantAju Pharm Co., Ltd.
Decision Date2020-12-15
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fixone All Suture Anchor is a medical device manufactured by Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2020-12-15 under approval number K192709. 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 Fixone All Suture Anchor?

Fixone All Suture Anchor is a medical device that received FDA 510(k) clearance on 2020-12-15. It is manufactured by Aju Pharm Co., Ltd.. The 510(k) number is K192709.

When was Fixone All Suture Anchor approved by the FDA?

Fixone All Suture Anchor received FDA 510(k) clearance on 2020-12-15, under approval number K192709.

What company makes Fixone All Suture Anchor?

Fixone All Suture Anchor is manufactured by Aju Pharm Co., Ltd..

What is the FDA product code for Fixone All Suture Anchor?

The FDA product code for Fixone All 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 Aju Pharm Co., Ltd.

K171299Fixone Biocomposite Anchor K162070JOINIX CANNULAR SYSTEM K192484Fixone Biocomposite Anchor K192032Fixone Biocomposite Small Anchor K203523Fixone hybrid knotless anchor K193497Fixone Biocomposite Interference Screw

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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

View on FDA Database →

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

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