Clearance Summary
OmniPore DUROMAX Surgical Implants received FDA 510(k) clearance under submission number K180249, sponsored by Matrix Surgical Holdings, LLC/Matrix Surgical USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-10-11.
- Submission: K180249
- Applicant / Sponsor: Matrix Surgical Holdings, LLC/Matrix Surgical USA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2018-10-11
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.