ANAX 5.5 Spinal System

Orthosis, Spondylolisthesis Spinal Fixation

U&I Corporation

The following data is part of a premarket notification filed by U&i Corporation with the FDA for Anax 5.5 Spinal System.

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
08800015972468	K143417	000
08800015972314	K143417	000
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