Arthrex TensionLoc System
K-Number: K183628 · 2019-03-26
ApplicantArthrex, Inc.
Decision Date2019-03-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Arthrex TensionLoc System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-03-26 under approval number K183628. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Arthrex TensionLoc System?
Arthrex TensionLoc System is a medical device that received FDA 510(k) clearance on 2019-03-26. It is manufactured by Arthrex, Inc.. The 510(k) number is K183628.
When was Arthrex TensionLoc System approved by the FDA?
Arthrex TensionLoc System received FDA 510(k) clearance on 2019-03-26, under approval number K183628.
What company makes Arthrex TensionLoc System?
Arthrex TensionLoc System is manufactured by Arthrex, Inc..
What is the FDA product code for Arthrex TensionLoc System?
The FDA product code for Arthrex TensionLoc System is HWC. This falls under the Cardiovascular category.
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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.