Clearance Summary
PROGENIX received FDA 510(k) clearance under submission number K082463, sponsored by Medtronic Sofamor Danek. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-11-10.
- Submission: K082463
- Applicant / Sponsor: Medtronic Sofamor Danek
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2008-11-10
Classification & Regulation
This clearance is catalogued under FDA product code NUN and 21 CFR 872.3930, within the Dental review panel as a Class II device.