TnR Cranial Implant— 510(k) K251959

Substantially Equivalent

T&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.

Clearance details

Applicant: T&R BIOFAB CO., Ltd.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 2025-06-26
Decision date: 2026-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXP

K261265 — Permatage XT Settable Bone Putty2026-06-15
K253732 — Permatage Flowable, Settable Bone Paste2026-03-13
K253854 — MONTAGE XT Cranial Cement2026-01-02
K241027 — Permatage Settable Bone Putty2024-09-26
K232771 — Montage Flowable Settable, Resorbable Bone Paste2024-02-16

More clearances from T&R BIOFAB CO., Ltd.

K222057 — THERMOCLICK2023-12-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.