Clearance Summary
ADI Cervical Interbody Fusion Device received FDA 510(k) clearance under submission number K191812, sponsored by Additive Device, Inc. (Adi) D/B/A Restor3D. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-10-24.
- Submission: K191812
- Applicant / Sponsor: Additive Device, Inc. (Adi) D/B/A Restor3D
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2019-10-24
Classification & Regulation
This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.