PPT · Class II · 21 CFR 882.4310

FDA Product Code PPT: Cranial Surgical Planning And Instrument Guides

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.

Leading manufacturers include Materialise NV.

1
Total
1
Cleared
100d
Avg days
2026
Since

List of Cranial Surgical Planning And Instrument Guides devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Jan 07, 2026
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides
K253308
Materialise NV
Neurology · 100d

How to use this database

This page lists all FDA 510(k) submissions for Cranial Surgical Planning And Instrument Guides devices (product code PPT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Neurology FDA review panel. Browse all Neurology devices →