FDA 510(k)

TnR Cranial Implant

K-Number: K251959 · 2026-07-30

Decision Date2026-07-30

Product CodeGXP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TnR Cranial Implant is the device name listed in this FDA 510(k) record. The listed applicant is T&R BIOFAB CO., Ltd.. It received FDA 510(k) clearance on 2026-07-30 under 510(k) number K251959. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TnR Cranial Implant?

TnR Cranial Implant is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is T&R BIOFAB CO., Ltd.. The 510(k) number is K251959.

When did TnR Cranial Implant receive FDA 510(k) clearance?

TnR Cranial Implant received FDA 510(k) clearance on 2026-07-30, under 510(k) number K251959.

Who is the listed applicant for TnR Cranial Implant?

The FDA 510(k) record lists T&R BIOFAB CO., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TnR Cranial Implant?

The FDA product code for TnR Cranial Implant is GXP.

Other records listing T&R BIOFAB CO., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222057THERMOCLICK

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.