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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K173080
Device Name IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
Applicant
Huvexel Co. , Ltd.
101-105 Megacenter, Sk Technopark, 124, Sagimakgol-Ro
Jungwon-Gu
Seongnam-Si,  KR 13207
Applicant Contact Sung Hee-Lee
Correspondent
Dio Medical Corporation
8770 W. Bryn Mawr Ave., Suite 1250
Chicago,  IL  60631
Correspondent Contact Milan George
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received09/29/2017
Decision Date 10/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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