PPT · Cranial Surgical Planning And Instrument Guides
Neurology · 21 CFR 882.4310 · Class 2
Overview
| Product Code | PPT |
|---|---|
| Device Name | Cranial Surgical Planning And Instrument Guides |
| Regulation | 21 CFR 882.4310 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | Materialise NV | Jan 7, 2026 | SESE |
| K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | Aug 31, 2020 | SESE |
| K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | Jul 26, 2019 | SESE |
| K151285 | VSP Cranial System | 3D Systems, Inc. | Sep 23, 2016 | SESE |
Top Applicants
- KLS-Martin L.P. — 2 clearances
- 3D Systems, Inc. — 1 clearance
- Materialise NV — 1 clearance
