Clearance Summary
Spinal Elements Ti-Bond coated devices received FDA 510(k) clearance under submission number K181837, sponsored by Spinal Elements, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-11-02.
- Submission: K181837
- Applicant / Sponsor: Spinal Elements, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2018-11-02
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.