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FDA 510(k)

Arthrex Syndesmosis TightRope XP Buttress Plate Implant System

K-Number: K201522 · 2020-09-03

ApplicantArthrex, Inc.
Decision Date2020-09-03
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K201522. 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 Syndesmosis TightRope XP Buttress Plate Implant System?

Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Arthrex, Inc.. The 510(k) number is K201522.

When did Arthrex Syndesmosis TightRope XP Buttress Plate Implant System receive FDA 510(k) clearance?

Arthrex Syndesmosis TightRope XP Buttress Plate Implant System received FDA 510(k) clearance on 2020-09-03, under 510(k) number K201522.

Who is the listed applicant for Arthrex Syndesmosis TightRope XP Buttress Plate Implant System?

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 Syndesmosis TightRope XP Buttress Plate Implant System?

The FDA product code for Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is HTN.

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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