Cleared Traditional

Spinal fixation system

K161151 · Canwell Medical Co., Ltd. · Orthopedic
Sep 2016
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K161151 is an FDA 510(k) clearance for the Spinal fixation system, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Canwell Medical Co., Ltd. (Jinhua, CN). The FDA issued a Cleared decision on September 21, 2016, 149 days after receiving the submission on April 25, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K161151 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2016
Decision Date September 21, 2016
Days to Decision 149 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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