Clearance Summary
FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) received FDA 510(k) clearance under submission number K081067, sponsored by Biomet Microfixation, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-05-09.
- Submission: K081067
- Applicant / Sponsor: Biomet Microfixation, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2008-05-09
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.