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FDA 510(k)

HEALICOIL Knotless Suture Anchors

K-Number: K193558 · 2020-03-18

ApplicantSmith & Nephew, Inc.
Decision Date2020-03-18
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALICOIL Knotless Suture Anchors is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2020-03-18 under approval 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. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K193558.

When was HEALICOIL Knotless Suture Anchors approved by the FDA?

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

What company makes HEALICOIL Knotless Suture Anchors?

HEALICOIL Knotless Suture Anchors is manufactured by Smith & Nephew, Inc..

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

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

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Related Devices (Code: MAI)

K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed 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.

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