Clearance Summary
3D MAC Titanium Cranial Plate (TCP) System received FDA 510(k) clearance under submission number K253116, sponsored by The Surgeon General, Department of the Army (TSG-DA). The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-06-18.
- Submission: K253116
- Applicant / Sponsor: The Surgeon General, Department of the Army (TSG-DA)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5330
- Decision date: 2026-06-18
Classification & Regulation
This clearance is catalogued under FDA product code GXN and 21 CFR 882.5330, within the Neurology review panel as a Class II device.