Clearance Summary
ADI TiDAL Osteotomy Wedge received FDA 510(k) clearance under submission number K191047, 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 2019-11-05.
- Submission: K191047
- Applicant / Sponsor: Additive Device, Inc. (Adi) D/B/A Restor3D
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2019-11-05
Classification & Regulation
This clearance is catalogued under FDA product code PLF and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.