FDA 510(k)

FiberTak Suture Anchor

K-Number: K230568 · 2023-04-01

Decision Date2023-04-01

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FiberTak Suture Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2023-04-01 under approval number K230568. 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 FiberTak Suture Anchor?

FiberTak Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-04-01. It is manufactured by Arthrex, Inc.. The 510(k) number is K230568.

When was FiberTak Suture Anchor approved by the FDA?

FiberTak Suture Anchor received FDA 510(k) clearance on 2023-04-01, under approval number K230568.

What company makes FiberTak Suture Anchor?

FiberTak Suture Anchor is manufactured by Arthrex, Inc..

What is the FDA product code for FiberTak Suture Anchor?

The FDA product code for FiberTak Suture Anchor is MBI.

Other Devices by Arthrex, Inc.

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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.