TnR Cranial Implant— 510(k) K251959
Substantially EquivalentT&R BIOFAB CO., Ltd.
FDA 510(k) clearance K251959 for TnR Cranial Implant, Substantially Equivalent on 2026-07-30. Applicant: T&R BIOFAB CO., Ltd.. Device class: 2.
Summary
T&R Biofab's TnR Cranial Implant is filed under GXP, methyl methacrylate for cranioplasty. The record doesn't describe the implant's design or sizes.
Class II, 21 CFR 882.5300. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
T&R Biofab filed from Gyeonggi-do, South Korea. Review took 399 calendar days (June 26, 2025 to July 30, 2026).
Clearance details
- Applicant
- T&R BIOFAB CO., Ltd.
- Product code
- Product code GXP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5300
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gyeonggi-Do, KR
Recent devices under product code GXP
view allMore clearances from T&R BIOFAB CO., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.