Clearance Summary
Delphos Implants Rigid Fixation System received FDA 510(k) clearance under submission number K182609, sponsored by Delphos Implants - Ind.Com. Importacao E Exportacao DE. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-03-29.
- Submission: K182609
- Applicant / Sponsor: Delphos Implants - Ind.Com. Importacao E Exportacao DE
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2019-03-29
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.