Clearance Summary
LOCK-IN Spinal Fixation System received FDA 510(k) clearance under submission number K243281, sponsored by Lock-In USA Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-12-13.
- Submission: K243281
- Applicant / Sponsor: Lock-In USA Corp
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2024-12-13
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.