3D MAC Titanium Cranial Plate (TCP) System
FDA 510(k) K253116 · The Surgeon General, Department of the Army (TSG-DA)
510(k) numberK253116
Submission
- Device name
- 3D MAC Titanium Cranial Plate (TCP) System
- Applicant
- The Surgeon General, Department of the Army (TSG-DA)
Fort Detrick, MD, US - Received
- September 24, 2025
- Decision date
- June 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was 3D MAC Titanium Cranial Plate (TCP) System cleared by the FDA?
3D MAC Titanium Cranial Plate (TCP) System (K253116) received a 510(k) decision of Substantially Equivalent on June 18, 2026, 267 days after the submission was received.
What is the product code of K253116?
The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.