Cleared Traditional

Xtreme-Loop

K191053 · Xiros, Ltd. · Orthopedic
Jul 2019
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K191053 is an FDA 510(k) clearance for the Xtreme-Loop, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on July 17, 2019, 89 days after receiving the submission on April 19, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K191053 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2019
Decision Date July 17, 2019
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040