The following data is part of a premarket notification filed by Huvexel Co., Ltd with the FDA for Iva Cage Ti (acif, Plif, Tlif, Dlif, And Alif).
Device ID | K173080 |
510k Number | K173080 |
Device Name: | IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, And ALIF) |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Huvexel Co., Ltd 101-105 Megacenter, SK Technopark, 124, Sagimakgol-ro Jungwon-gu Seongnam-si, KR 13207 |
Contact | Sung Hee-lee |
Correspondent | Milan George Dio Medical Corporation 8770 W Bryn Mawr Ave. Ste. 1250 Chicago, IL 60631 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-29 |
Decision Date | 2017-10-31 |
Summary: | summary |