Clearance Summary
ORTHOMEND received FDA 510(k) clearance under submission number K031188, sponsored by Tei Biosciences, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2003-06-27.
- Submission: K031188
- Applicant / Sponsor: Tei Biosciences, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2003-06-27
Classification & Regulation
This clearance is catalogued under FDA product code FTL and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.