K253116
- 510(k) number
- K253116
- Device name
- 3D MAC Titanium Cranial Plate (TCP) System
- Applicant
- The Surgeon General, Department of the Army (TSG-DA) MD · US
- Product code
- GXN — Plate, Cranioplasty, Preformed, Non-Alterable
- Decision date
- 2026-06-18
- Date received
- 2025-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253116.pdf
Official FDA record: K253116
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.