FDA 510(k)

INVISIKNOT Ankle Syndesmosis Repair Kit

K-Number: K162996 · 2017-06-08

Decision Date2017-06-08

Product CodeHTN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

INVISIKNOT Ankle Syndesmosis Repair Kit is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) 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. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K162996.

When did INVISIKNOT Ankle Syndesmosis Repair Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for INVISIKNOT Ankle Syndesmosis Repair Kit?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Smith & Nephew, Inc. as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: HTN)

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek Medical K253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLC

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.