Clearance Summary
TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM received FDA 510(k) clearance under submission number K896369, sponsored by Techmedica, Inc.. 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 1989-11-24.
- Submission: K896369
- Applicant / Sponsor: Techmedica, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 1989-11-24
Classification & Regulation
This clearance is catalogued under FDA product code EZX and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.