Clearance Summary
Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) received FDA 510(k) clearance under submission number K232996, sponsored by Shanghai Iatrical-Ti Technologies CO , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-09-06.
- Submission: K232996
- Applicant / Sponsor: Shanghai Iatrical-Ti Technologies CO , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2024-09-06
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.