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FDA 510(k)

Acumed Ankle Syndesmosis Repair System

K-Number: K212990 · 2022-01-07

ApplicantAcumed, LLC
Decision Date2022-01-07
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Acumed Ankle Syndesmosis Repair System is a medical device manufactured by Acumed, LLC. It received FDA 510(k) clearance on 2022-01-07 under approval number K212990. 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 Acumed Ankle Syndesmosis Repair System?

Acumed Ankle Syndesmosis Repair System is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Acumed, LLC. The 510(k) number is K212990.

When was Acumed Ankle Syndesmosis Repair System approved by the FDA?

Acumed Ankle Syndesmosis Repair System received FDA 510(k) clearance on 2022-01-07, under approval number K212990.

What company makes Acumed Ankle Syndesmosis Repair System?

Acumed Ankle Syndesmosis Repair System is manufactured by Acumed, LLC.

What is the FDA product code for Acumed Ankle Syndesmosis Repair System?

The FDA product code for Acumed Ankle Syndesmosis Repair System is HTN.

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Other Devices by Acumed, LLC

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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

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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