Clearance Summary
KMTI S141 Lumbar Interbody Fusion System received FDA 510(k) clearance under submission number K212070, sponsored by Kyocera Medical Technologies, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-08-30.
- Submission: K212070
- Applicant / Sponsor: Kyocera Medical Technologies, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2021-08-30
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.