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FDA 510(k)

Knotless SutureTak Anchors

K-Number: K180594 · 2018-06-22

ApplicantArthrex, Inc.
Decision Date2018-06-22
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Knotless SutureTak Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K180594. 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 Knotless SutureTak Anchors?

Knotless SutureTak Anchors is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Arthrex, Inc.. The 510(k) number is K180594.

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

Knotless SutureTak Anchors received FDA 510(k) clearance on 2018-06-22, under 510(k) number K180594.

Who is the listed applicant for Knotless SutureTak Anchors?

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

What is the FDA product code for Knotless SutureTak Anchors?

The FDA product code for Knotless SutureTak Anchors is MAI.

Other records listing Arthrex, Inc. as applicant

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButtonK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemK253931Arthrex Bioabsorbable PushLock Suture AnchorsK254215Arthrex Beaming System

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Related Devices (Code: MAI)

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® 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.

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