PPT

Cranial Surgical Planning And Instrument Guides

Product code: PPT
Device name: Cranial Surgical Planning And Instrument Guides
Device class: Class 2
21 CFR: 21 CFR 882.4310
Medical specialty: Neurology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 4

FDA classification definition

Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-01-07.

Number	Decision date	Applicant	Device name	Summary
K253308	2026-01-07	Materialise NV	Materialise Personalized Guides and Models for Crani	PDF

1 summaries are archived here for direct download.

Official FDA classification page: PPT

Classification and pathway per current FDA publications. Data from openFDA (CC0).