Home / 510(k) Clearances / K253116

510(k) K253116

3D MAC Titanium Cranial Plate (TCP) System by The Surgeon General, Department of the Army (TSG-DA) — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
September 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

Other clearances by The Surgeon General, Department of the Army (TSG-DA)

  • K233249 — APPRAISE-HRI (April 5, 2024)

Other clearances for product code GXN

  • K252251 — EASYMADE-TI (April 9, 2026)
  • K252958 — METICULY Patient-specific titanium mesh implant (January 14, 2026)
  • K243715 — Synthes Patient Specific Implants (November 12, 2025)
  • K252573 — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosyn (November 10, 2025)
  • K240567 — CustomizedBone Service (March 28, 2024)
  • K231920 — Longeviti ClearFit OTS Cranial Implant (November 9, 2023)
  • K214109 — PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) (October 28, 2022)
  • K220357 — MedCAD AccuShape Titanium Patient-Specific Cranial Implant (August 26, 2022)
  • K210099 — Meticuly Patient-Specific Titanium Mesh Implant (December 21, 2021)
  • K212058 — Longeviti ClearFit™ OTS Cranial Implants (September 8, 2021)