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 a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-09-03 under approval 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. It is manufactured by Arthrex, Inc.. The 510(k) number is K201522.
When was Arthrex Syndesmosis TightRope XP Buttress Plate Implant System approved by the FDA?
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System received FDA 510(k) clearance on 2020-09-03, under approval number K201522.
What company makes Arthrex Syndesmosis TightRope XP Buttress Plate Implant System?
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is manufactured by Arthrex, Inc..
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.
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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.