FDA 510(k)

Akros FibuLink Syndesmosis Repair Kit

K-Number: K173550 · 2017-12-14

Decision Date2017-12-14

Product CodeHTN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Akros FibuLink Syndesmosis Repair Kit is a medical device manufactured by Akros Medical. It received FDA 510(k) clearance on 2017-12-14 under approval number K173550. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Akros FibuLink Syndesmosis Repair Kit?

Akros FibuLink Syndesmosis Repair Kit is a medical device that received FDA 510(k) clearance on 2017-12-14. It is manufactured by Akros Medical. The 510(k) number is K173550.

When was Akros FibuLink Syndesmosis Repair Kit approved by the FDA?

Akros FibuLink Syndesmosis Repair Kit received FDA 510(k) clearance on 2017-12-14, under approval number K173550.

What company makes Akros FibuLink Syndesmosis Repair Kit?

Akros FibuLink Syndesmosis Repair Kit is manufactured by Akros Medical.

What is the FDA product code for Akros FibuLink Syndesmosis Repair Kit?

The FDA product code for Akros FibuLink Syndesmosis Repair Kit is HTN.

Other Devices by Akros Medical

K162805Akros Fibulink Syndesmosis Repair Kit K200361Akros Scruture Anchor LisFranc Repair Kit

Related Devices (Code: HTN)

K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc. K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC K170249GRAVITY Syndesmosis LPWrightmedicaltechnologyinc K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc. K170440KISSloc Suture SystemArthrosurface, Inc. K162805Akros Fibulink Syndesmosis Repair KitAkros Medical

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.