K251959
- 510(k) number
- K251959
- Device name
- TnR Cranial Implant
- Applicant
- T&R BIOFAB CO., Ltd. KR
- Product code
- GXP — Methyl Methacrylate For Cranioplasty
- Decision date
- 2026-07-30
- Date received
- 2025-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251959.pdf
Official FDA record: K251959
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.