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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2019-03-26 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K183628.

When did Arthrex TensionLoc System receive FDA 510(k) clearance?

Arthrex TensionLoc System received FDA 510(k) clearance on 2019-03-26, under 510(k) number K183628.

Who is the listed applicant for Arthrex TensionLoc 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 TensionLoc System?

The FDA product code for Arthrex TensionLoc System is HWC. This falls under the Cardiovascular category.

Other records listing Arthrex, Inc. as applicant

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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.

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