Clearance Summary
INION CPS 2.0 ORTHOGNATHIC PLATE received FDA 510(k) clearance under submission number K013039, sponsored by Inion , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-10-05.
- Submission: K013039
- Applicant / Sponsor: Inion , Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2001-10-05
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.