Clearance Summary
INTRAORAL MANDIBULAR DISTRACTION SYSTEM received FDA 510(k) clearance under submission number K013618, sponsored by Osteomed Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-08-14.
- Submission: K013618
- Applicant / Sponsor: Osteomed Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2002-08-14
Classification & Regulation
This clearance is catalogued under FDA product code MQN and 21 CFR 872.4760, within the Dental review panel as a Class II device.