HC Spinal System

Orthosis, Spondylolisthesis Spinal Fixation

HUNG CHUN BIO-S CO., LTD.

The following data is part of a premarket notification filed by Hung Chun Bio-s Co., Ltd. with the FDA for Hc Spinal System.

Pre-market Notification Details

Device IDK151362
510k NumberK151362
Device Name:HC Spinal System
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant HUNG CHUN BIO-S CO., LTD. NO.12, LUKE 1ST RD., LUZHU DIST., Kaohsiung City,  TW 821
ContactHsin Tai Hu
CorrespondentMichael Lee
ACMEBIOTECHS CONSULTING INCORPORATION 38F-7, NO.368, SEC. 1, WENHUA RD., BANQIAO DIST., New Taipei City,  TW 22041
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-21
Decision Date2016-05-05
Summary:summary

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