Clearance Summary
THERMOFX MESH received FDA 510(k) clearance under submission number K003757, sponsored by Bionx Implants, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-02-07.
- Submission: K003757
- Applicant / Sponsor: Bionx Implants, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2001-02-07
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.