Clearance Summary
Companion Spine DIAM Instrumentation received FDA 510(k) clearance under submission number K253118, sponsored by Companion Spine France. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-12-16.
- Submission: K253118
- Applicant / Sponsor: Companion Spine France
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.4520
- Decision date: 2025-12-16
Classification & Regulation
This clearance is catalogued under FDA product code QLR and 21 CFR 888.4520, within the Orthopedic review panel as a Class II device.