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FDA 510(k)

INVISIKNOT Ankle Syndesmosis Repair Kit

K-Number: K162996 · 2017-06-08

ApplicantSmith & Nephew, Inc.
Decision Date2017-06-08
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INVISIKNOT Ankle Syndesmosis Repair Kit is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-06-08 under approval number K162996. 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 INVISIKNOT Ankle Syndesmosis Repair Kit?

INVISIKNOT Ankle Syndesmosis Repair Kit is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K162996.

When was INVISIKNOT Ankle Syndesmosis Repair Kit approved by the FDA?

INVISIKNOT Ankle Syndesmosis Repair Kit received FDA 510(k) clearance on 2017-06-08, under approval number K162996.

What company makes INVISIKNOT Ankle Syndesmosis Repair Kit?

INVISIKNOT Ankle Syndesmosis Repair Kit is manufactured by Smith & Nephew, Inc..

What is the FDA product code for INVISIKNOT Ankle Syndesmosis Repair Kit?

The FDA product code for INVISIKNOT Ankle Syndesmosis Repair Kit is HTN.

Related Clinical Trials

NCT06829667 Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability COMPLETED NCT06638138 Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability COMPLETED NCT07498166 Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair ACTIVE_NOT_RECRUITING

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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 K170440KISSloc Suture SystemArthrosurface, Inc. K162805Akros Fibulink Syndesmosis Repair KitAkros Medical

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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