Cleared Traditional

Double Medical Universal Spine System

K151458 · Double Medical Technology, Inc. · Orthopedic
Aug 2016
Decision
448d
Days
Class 2
Risk

About This 510(k) Submission

K151458 is an FDA 510(k) clearance for the Double Medical Universal Spine System, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on August 22, 2016, 448 days after receiving the submission on June 1, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K151458 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2015
Decision Date August 22, 2016
Days to Decision 448 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNI — Orthosis, Spinal Pedicle Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070

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