Cleared Traditional

HC Spinal System

K151362 · Hung Chun Bio-S Co., Ltd. · Orthopedic
May 2016
Decision
350d
Days
Class 2
Risk

About This 510(k) Submission

K151362 is an FDA 510(k) clearance for the HC Spinal System, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Hung Chun Bio-S Co., Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on May 5, 2016, 350 days after receiving the submission on May 21, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K151362 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2015
Decision Date May 05, 2016
Days to Decision 350 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