TnR Cranial Implant

FDA 510(k) K251959 · T&R BIOFAB CO., Ltd.

Substantially Equivalent

510(k) numberK251959

Submission

Device name
TnR Cranial Implant
Applicant
T&R BIOFAB CO., Ltd.
Gyeonggi-Do, KR
Received
June 26, 2025
Decision date
July 30, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXP – Methyl Methacrylate For Cranioplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5300
Specialty
Neurology
Implant
Yes

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K221933MONTAGE Settable, Resorbable Bone PuttyGXP · Traditional Orthocon, Inc.01/13/2023SE
K182742Db-CmfGXP · Traditional Dimensional Bioceramics, LLC06/20/2019SE
K162864OsteoVation ImpactGXP · Traditional Skeletal Kinetics, LLC01/13/2017SE
K143661DirectInjectGXP · Traditional Stryker09/02/2015SE

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Questions and answers

When was TnR Cranial Implant cleared by the FDA?

TnR Cranial Implant (K251959) received a 510(k) decision of Substantially Equivalent on July 30, 2026, 399 days after the submission was received.

What is the product code of K251959?

The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.