Spinal Inner Fixation System

Thoracolumbosacral Pedicle Screw System

Changzhou Geasure Medical Apparatus And Instruments Co., Ltd

The following data is part of a premarket notification filed by Changzhou Geasure Medical Apparatus And Instruments Co., Ltd with the FDA for Spinal Inner Fixation System.

Pre-market Notification Details

Device IDK222031
510k NumberK222031
Device Name:Spinal Inner Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Changzhou Geasure Medical Apparatus And Instruments Co., Ltd No. 12, Jinfeng Road West Taihu Science And Technology Industrial Park Changzhou,  CN 213149
ContactJing Huang
CorrespondentXiaoqing Xue
Sinow Medical AS Vestre Fantoftasen 44, 5072, Bergen, Norway Bergen,  NO
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-11
Decision Date2022-10-28

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