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 |