Cleared Traditional

Bolo Button System

K242091 · Fusion Orthopedics · Orthopedic
Dec 2024
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K242091 is an FDA 510(k) clearance for the Bolo Button System, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Fusion Orthopedics (Mesa, US). The FDA issued a Cleared decision on December 23, 2024, 159 days after receiving the submission on July 17, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K242091 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2024
Decision Date December 23, 2024
Days to Decision 159 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