CB PROT II Posterior Spinal System

Orthosis, Spondylolisthesis Spinal Fixation

CHIN BONE TECHNIQUE CORP

The following data is part of a premarket notification filed by Chin Bone Technique Corp with the FDA for Cb Prot Ii Posterior Spinal System.

Pre-market Notification Details

Device IDK142655
510k NumberK142655
Device Name:CB PROT II Posterior Spinal System
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant CHIN BONE TECHNIQUE CORP 1F., NO. 165, SEC, 2, XIAN ST., BEITOU DIST. Taipei,  TW 11274
ContactCheng-kung Cheng
CorrespondentCheng-kung Cheng
CHIN BONE TECHNIQUE CORP NO. 165, SEC, 2, XIAN ST., BEITOU DIST. Taipei,  CN 11274
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-18
Decision Date2015-01-26
Summary:summary

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