Clearance Summary
TnR Cranial Implant received FDA 510(k) clearance under submission number K251959, sponsored by T&R BIOFAB CO., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-07-30.
- Submission: K251959
- Applicant / Sponsor: T&R BIOFAB CO., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5300
- Decision date: 2026-07-30
Classification & Regulation
This clearance is catalogued under FDA product code GXP and 21 CFR 882.5300, within the Neurology review panel as a Class II device.