Clearance Summary
Dymaxeon Spine System received FDA 510(k) clearance under submission number K192930, 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 2020-05-12.
- Submission: K192930
- 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: 2020-05-12
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.