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FDA 510(k)

3D MAC Titanium Cranial Plate (TCP) System

K-Number: K253116 · 2026-06-18

ApplicantThe Surgeon General, Department of the Army (TSG-DA)
Decision Date2026-06-18
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

3D MAC Titanium Cranial Plate (TCP) System is the device name listed in this FDA 510(k) record. The listed applicant is The Surgeon General, Department of the Army (TSG-DA). It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253116. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D MAC Titanium Cranial Plate (TCP) System?

3D MAC Titanium Cranial Plate (TCP) System is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is The Surgeon General, Department of the Army (TSG-DA). The 510(k) number is K253116.

When did 3D MAC Titanium Cranial Plate (TCP) System receive FDA 510(k) clearance?

3D MAC Titanium Cranial Plate (TCP) System received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253116.

Who is the listed applicant for 3D MAC Titanium Cranial Plate (TCP) System?

The FDA 510(k) record lists The Surgeon General, Department of the Army (TSG-DA) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D MAC Titanium Cranial Plate (TCP) System?

The FDA product code for 3D MAC Titanium Cranial Plate (TCP) System is GXN.

Other records listing The Surgeon General, Department of the Army (TSG-DA) 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.

K233249APPRAISE-HRI

Related Devices (Code: GXN)

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.

K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)Longeviti Neuro SolutionsK252251EASYMADE-TICG Bio Co., Ltd.K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.K243715Synthes Patient Specific ImplantsSynthes GmbHK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEKLS-Martin L.P.K240567CustomizedBone ServiceFin-Ceramica Faenza S.P.A.

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.

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