FDA 510(k)

Akros Scruture Anchor LisFranc Repair Kit

K-Number: K200361 · 2020-04-06

Decision Date2020-04-06

Product CodeHTN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Akros Scruture Anchor LisFranc Repair Kit is a medical device manufactured by Akros Medical. It received FDA 510(k) clearance on 2020-04-06 under approval number K200361. 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 Scruture Anchor LisFranc Repair Kit?

Akros Scruture Anchor LisFranc Repair Kit is a medical device that received FDA 510(k) clearance on 2020-04-06. It is manufactured by Akros Medical. The 510(k) number is K200361.

When was Akros Scruture Anchor LisFranc Repair Kit approved by the FDA?

Akros Scruture Anchor LisFranc Repair Kit received FDA 510(k) clearance on 2020-04-06, under approval number K200361.

What company makes Akros Scruture Anchor LisFranc Repair Kit?

Akros Scruture Anchor LisFranc Repair Kit is manufactured by Akros Medical.

What is the FDA product code for Akros Scruture Anchor LisFranc Repair Kit?

The FDA product code for Akros Scruture Anchor LisFranc Repair Kit is HTN.

Other Devices by Akros Medical

K173550Akros FibuLink Syndesmosis Repair Kit K162805Akros Fibulink Syndesmosis Repair Kit

Related Devices (Code: HTN)

K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc. K173550Akros FibuLink Syndesmosis Repair KitAkros Medical K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC K170249GRAVITY Syndesmosis LPWrightmedicaltechnologyinc K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc. K170440KISSloc Suture SystemArthrosurface, Inc.

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.