Cleared Traditional

TENSOR? Suture Button System

K240947 · Globus Medical, Inc. · Orthopedic
Jun 2024
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K240947 is an FDA 510(k) clearance for the TENSOR? Suture Button System, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on June 3, 2024, 56 days after receiving the submission on April 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K240947 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2024
Decision Date June 03, 2024
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030