Clearance Summary
OMNIPORE CUSTOMIZED SURGICAL IMPLANTS received FDA 510(k) clearance under submission number K133046, sponsored by Matrix Surgical Holdings, LLC/Matrix Surgical USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2014-05-14.
- Submission: K133046
- Applicant / Sponsor: Matrix Surgical Holdings, LLC/Matrix Surgical USA
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3500
- Decision date: 2014-05-14
Classification & Regulation
This clearance is catalogued under FDA product code KKY and 21 CFR 878.3500, within the General, Plastic Surgery review panel as a Class II device.