Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arthrex SwiveLock Anchor

K-Number: K203495 · 2021-04-19

ApplicantArthrex, Inc.
Decision Date2021-04-19
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex SwiveLock Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2021-04-19 under 510(k) number K203495. 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 Anchor?

Arthrex SwiveLock Anchor is a medical device that received FDA 510(k) clearance on 2021-04-19. The listed applicant is Arthrex, Inc.. The 510(k) number is K203495.

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

Arthrex SwiveLock Anchor received FDA 510(k) clearance on 2021-04-19, under 510(k) number K203495.

Who is the listed applicant for Arthrex SwiveLock Anchor?

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 Anchor?

The FDA product code for Arthrex SwiveLock Anchor 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

View all 173 devices →

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.

↑