Cleared Traditional

SECURE-LOOP

K151601 · Xiros, Ltd. · Orthopedic
Sep 2015
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K151601 is an FDA 510(k) clearance for the SECURE-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 September 9, 2015, 89 days after receiving the submission on June 12, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K151601 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2015
Decision Date September 09, 2015
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