Cleared Traditional

Infinity-Lock Button System

K180243 · Xiros, Ltd. · Orthopedic
Apr 2018
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K180243 is an FDA 510(k) clearance for the Infinity-Lock Button System, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on April 3, 2018, 64 days after receiving the submission on January 29, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K180243 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2018
Decision Date April 03, 2018
Days to Decision 64 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