Clearance Summary
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 received FDA 510(k) clearance under submission number K093390, sponsored by Depuy Spine, 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 2010-05-25.
- Submission: K093390
- Applicant / Sponsor: Depuy Spine, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2010-05-25
Classification & Regulation
This clearance is catalogued under FDA product code LYC and 21 CFR 872.3930, within the Dental review panel as a Class II device.