Cranial Surgical Planning And Instrument Guides
The Cranial Surgical Planning and Instrument Guides system consists of software and hardware for neurosurgical planning, used to create patient-specific anatomical models, surgical templates, and guides for marking or cutting cranial bone in neurosurgical procedures. It is classified as FDA Class 2 under 21 CFR 882.4310 in the Neurology specialty, requiring 510(k) premarket notification. The device assists surgeons in precise cranial access planning based on pre-operative imaging. Product code PPT; not an implant and not life-sustaining.
Research product code PPT in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PPT
- Device Class
- FDA class 2
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | Jan 07, 2026 | Substantially Equivalent | Materialise NV |
| K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | Aug 31, 2020 | Substantially Equivalent | KLS-Martin L.P. |
| K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System | Jul 26, 2019 | Substantially Equivalent | KLS-Martin L.P. |
| K151285 | VSP Cranial System | Sep 23, 2016 | Substantially Equivalent | 3D Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.