Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FiberTak DX

K-Number: K172612 · 2017-09-28

ApplicantArthex, Inc.
Decision Date2017-09-28
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FiberTak DX is a medical device manufactured by Arthex, Inc.. It received FDA 510(k) clearance on 2017-09-28 under approval number K172612. 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 DX?

FiberTak DX is a medical device that received FDA 510(k) clearance on 2017-09-28. It is manufactured by Arthex, Inc.. The 510(k) number is K172612.

When was FiberTak DX approved by the FDA?

FiberTak DX received FDA 510(k) clearance on 2017-09-28, under approval number K172612.

What company makes FiberTak DX?

FiberTak DX is manufactured by Arthex, Inc..

What is the FDA product code for FiberTak DX?

The FDA product code for FiberTak DX is MBI.

Other Devices by Arthex, Inc.

K223759Arthrex SynergyID Endoscopic Imaging 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

View on FDA Database →

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

↑