Clearance Summary
LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE received FDA 510(k) clearance under submission number K000594, sponsored by Stryker Leibinger. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-12-08.
- Submission: K000594
- Applicant / Sponsor: Stryker Leibinger
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2000-12-08
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.