Clearance Summary
Orthobond Mariner Pedicle Screw System received FDA 510(k) clearance under submission number DEN220015, sponsored by Orthobond Coporation. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-04-05.
- Submission: DEN220015
- Applicant / Sponsor: Orthobond Coporation
- Clearance pathway: Direct
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3071
- Decision date: 2024-04-05
Classification & Regulation
This clearance is catalogued under FDA product code QZY and 21 CFR 888.3071, within the Orthopedic review panel as a Class II device.