Clearance Summary
Ruthless Spine RJB received FDA 510(k) clearance under submission number K243375, sponsored by Ruthless, LLC Dba Ruthless Spine. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-11-29.
- Submission: K243375
- Applicant / Sponsor: Ruthless, LLC Dba Ruthless Spine
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.4560
- Decision date: 2024-11-29
Classification & Regulation
This clearance is catalogued under FDA product code QWL and 21 CFR 888.4560, within the Orthopedic review panel as a Class II device.