Velofix™ TLIF Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

U&i Corporation

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

Pre-market Notification Details

• Device ID: K172419
• 510k Number: K172419
• Device Name: Velofix™ TLIF Cage
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• 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: MAX
• 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: 2017-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800015961004	K172419	000
08800015961165	K172419	000
08800015961172	K172419	000
08800015961189	K172419	000
08800015961196	K172419	000
08800015961202	K172419	000
08800015961219	K172419	000
08800015961226	K172419	000
08800015961233	K172419	000
08800015961240	K172419	000
08800015961257	K172419	000
08800015961264	K172419	000
08800015961271	K172419	000
08800015961288	K172419	000
08800015961158	K172419	000
08800015961141	K172419	000
08800015961011	K172419	000
08800015961028	K172419	000
08800015961035	K172419	000
08800015961042	K172419	000
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08800015961066	K172419	000
08800015961073	K172419	000
08800015961080	K172419	000
08800015961097	K172419	000
08800015961103	K172419	000
08800015961110	K172419	000
08800015961127	K172419	000
08800015961134	K172419	000
08800015961295	K172419	000
08800015961301	K172419	000
08800015961462	K172419	000
08800015961479	K172419	000
08800015961486	K172419	000
08800015961493	K172419	000
08800015961509	K172419	000
08800015961516	K172419	000
08800015961523	K172419	000
08800015961530	K172419	000
08800015961547	K172419	000
08800015961554	K172419	000
08800015961561	K172419	000
08800015961578	K172419	000
08800015961585	K172419	000
08800015961455	K172419	000
08800015961448	K172419	000
08800015961318	K172419	000
08800015961325	K172419	000
08800015961332	K172419	000
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08800015961400	K172419	000
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08800015961431	K172419	000
08800015961592	K172419	000