Anatase Spine Surgery Navigation System, Model Number: SNS-Spine2-S And SNS-spine2-V

Orthopedic Stereotaxic Instrument

Remex Medical Corporation

The following data is part of a premarket notification filed by Remex Medical Corporation with the FDA for Anatase Spine Surgery Navigation System, Model Number: Sns-spine2-s And Sns-spine2-v.

Pre-market Notification Details

Device IDK220348
510k NumberK220348
Device Name:Anatase Spine Surgery Navigation System, Model Number: SNS-Spine2-S And SNS-spine2-V
ClassificationOrthopedic Stereotaxic Instrument
Applicant Remex Medical Corporation 4F., No. 9, Jingke Road, Nantun Dist. Taichung,  TW 408224
ContactChuang Shih-Chang
CorrespondentSandy Liu
Jin Services Co. 9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North District Tainan City,  TW 70447
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-07
Decision Date2022-07-14

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