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FDA 510(k)

TENSOR® Suture Button System

K-Number: K240947 · 2024-06-03

ApplicantGlobus Medical, Inc.
Decision Date2024-06-03
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TENSOR® Suture Button System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-06-03 under approval number K240947. 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 TENSOR® Suture Button System?

TENSOR® Suture Button System is a medical device that received FDA 510(k) clearance on 2024-06-03. It is manufactured by Globus Medical, Inc.. The 510(k) number is K240947.

When was TENSOR® Suture Button System approved by the FDA?

TENSOR® Suture Button System received FDA 510(k) clearance on 2024-06-03, under approval number K240947.

What company makes TENSOR® Suture Button System?

TENSOR® Suture Button System is manufactured by Globus Medical, Inc..

What is the FDA product code for TENSOR® Suture Button System?

The FDA product code for TENSOR® Suture Button System is HTN.

Related Clinical Trials

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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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