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)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

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.

1 summaries are archived here for direct download.