Clearance Summary
Dymaxeon Spine System received FDA 510(k) clearance under submission number K170989, sponsored by Back 2 Basics Direct, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-05-22.
- Submission: K170989
- Applicant / Sponsor: Back 2 Basics Direct, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2017-05-22
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.