Velofix™ SA Cervical Cage

Intervertebral Fusion Device With Integrated Fixation, Cervical

U&I Corporation

The following data is part of a premarket notification filed by U&i Corporation with the FDA for Velofix™ Sa Cervical Cage.

Pre-market Notification Details

• Device ID: K172424
• 510k Number: K172424
• Device Name: Velofix™ SA Cervical Cage
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: U&I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781
• Contact: Jee-ae Bang
• Correspondent: Jee-ae Bang; U&I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-10
• Decision Date: 2017-11-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800015960281	K172424	000
08800015960472	K172424	000
08800015960489	K172424	000
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08800037519771	K172424	000