Cleared Traditional

ATL Anchors

K200503 · International Life Sciences · Orthopedic
Sep 2020
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K200503 is an FDA 510(k) clearance for the ATL Anchors, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by International Life Sciences (Marietta, US). The FDA issued a Cleared decision on September 2, 2020, 184 days after receiving the submission on March 2, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K200503 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2020
Decision Date September 02, 2020
Days to Decision 184 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