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FDA 510(k)

Arthrex Knotless AC Repair Devices

K-Number: K220947 · 2022-06-06

ApplicantArthrex, Inc.
Decision Date2022-06-06
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Knotless AC Repair Devices is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2022-06-06 under 510(k) number K220947. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Knotless AC Repair Devices?

Arthrex Knotless AC Repair Devices is a medical device that received FDA 510(k) clearance on 2022-06-06. The listed applicant is Arthrex, Inc.. The 510(k) number is K220947.

When did Arthrex Knotless AC Repair Devices receive FDA 510(k) clearance?

Arthrex Knotless AC Repair Devices received FDA 510(k) clearance on 2022-06-06, under 510(k) number K220947.

Who is the listed applicant for Arthrex Knotless AC Repair Devices?

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 Knotless AC Repair Devices?

The FDA product code for Arthrex Knotless AC Repair Devices is HTN.

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Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: HTN)

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.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLC

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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