Clearance Summary
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) received FDA 510(k) clearance under submission number K173080, sponsored by Huvexel Co. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-10-31.
- Submission: K173080
- Applicant / Sponsor: Huvexel Co. , Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2017-10-31
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.