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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 the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-06-03 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K240947.

When did TENSOR® Suture Button System receive FDA 510(k) clearance?

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

Who is the listed applicant for TENSOR® Suture Button System?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for TENSOR® Suture Button 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.

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