ANAX™ OCT Spinal System

Posterior Cervical Screw System

U & I Corporation

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

Pre-market Notification Details

• Device ID: K183383
• 510k Number: K183383
• Device Name: ANAX™ OCT Spinal System
• Classification: Posterior Cervical Screw System
• Applicant: U & I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781
• Contact: Young Eun Lee
• Correspondent: Young Eun Lee; U & I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-06
• Decision Date: 2018-12-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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