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FDA 510(k)

Arthrex SwiveLock Anchors

K-Number: K171141 · 2017-05-04

ApplicantArthrex, Inc.
Decision Date2017-05-04
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex SwiveLock 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 2017-05-04 under 510(k) number K171141. 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 Arthrex SwiveLock Anchors?

Arthrex SwiveLock Anchors is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Arthrex, Inc.. The 510(k) number is K171141.

When did Arthrex SwiveLock Anchors receive FDA 510(k) clearance?

Arthrex SwiveLock Anchors received FDA 510(k) clearance on 2017-05-04, under 510(k) number K171141.

Who is the listed applicant for Arthrex SwiveLock 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 Arthrex SwiveLock Anchors?

The FDA product code for Arthrex SwiveLock 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.

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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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