Clearance Summary
M6-C Single Use, Disposable Instrumentation received FDA 510(k) clearance under submission number K241117, sponsored by Spinal Kinetics / Orthofix / Seaspine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-06-21.
- Submission: K241117
- Applicant / Sponsor: Spinal Kinetics / Orthofix / Seaspine
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.4515
- Decision date: 2024-06-21
Classification & Regulation
This clearance is catalogued under FDA product code QLQ and 21 CFR 888.4515, within the Orthopedic review panel as a Class II device.