Clearance Summary
MONDRIAN ALIF Cage with Supplementary Fixation Plate received FDA 510(k) clearance under submission number K213641, sponsored by Ctl Medical Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-09-15.
- Submission: K213641
- Applicant / Sponsor: Ctl Medical Corporation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2022-09-15
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.