Anax 5.5 Spinal System 510(k) FDA Premarket Notification K143417 U&I Corporation

Pre-market Notification Details

Device ID	K143417
510k Number	K143417
Device Name:	ANAX 5.5 Spinal System
Classification	Orthosis, Spondylolisthesis Spinal Fixation
Applicant	U&I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si,, KR 480-859
Contact	Young-geun Kim
Correspondent	Young-geun Kim U&I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do, KR 480-859
Product Code	MNH
CFR Regulation Number	888.3070 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2014-11-28
Decision Date	2015-02-25
Summary:	summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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08800015972482	K143417	000

ANAX 5.5 Spinal System

Orthosis, Spondylolisthesis Spinal Fixation

U&I Corporation

Pre-market Notification Details

NIH GUDID Devices