Sterile Posterior Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

Shanghai REACH Medical Instrument Co., Ltd

The following data is part of a premarket notification filed by Shanghai Reach Medical Instrument Co., Ltd with the FDA for Sterile Posterior Spinal Fixation System.

Pre-market Notification Details

Device IDK221745
510k NumberK221745
Device Name:Sterile Posterior Spinal Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Shanghai REACH Medical Instrument Co., Ltd Building 13, No.999 Jiangyue Road Minhang District Shanghai,  CN 201114
ContactMingsha Ye
CorrespondentHuifang Zhao
Sinow Medical AS Hoyteknologisenteret, Thormohlens gate 55 Bergen,  NO 5006
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-16
Decision Date2022-08-31

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