FDA 510(k)

HEALICOIL Knotless Suture Anchors

K-Number: K193558 · 2020-03-18

Decision Date2020-03-18

Product CodeMAI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HEALICOIL Knotless Suture Anchors 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 2020-03-18 under 510(k) number K193558. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALICOIL Knotless Suture Anchors?

HEALICOIL Knotless Suture Anchors is a medical device that received FDA 510(k) clearance on 2020-03-18. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K193558.

When did HEALICOIL Knotless Suture Anchors receive FDA 510(k) clearance?

HEALICOIL Knotless Suture Anchors received FDA 510(k) clearance on 2020-03-18, under 510(k) number K193558.

Who is the listed applicant for HEALICOIL Knotless Suture Anchors?

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 HEALICOIL Knotless Suture Anchors?

The FDA product code for HEALICOIL Knotless Suture Anchors is MAI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03985839Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and HipCOMPLETED NCT02440672JOURNEY™ II CR Total Knee SystemACTIVE_NOT_RECRUITING NCT03247023Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint ReplacementTERMINATED NCT04325022Safety and Effectiveness Study of OR3O™ Dual Mobility System in THAACTIVE_NOT_RECRUITING NCT04849884To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.COMPLETED NCT05444465Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness TearsRECRUITING

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: MAI)

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbH K254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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.