PPT — Cranial Surgical Planning And Instrument Guides Class II
Classification Details
- Product Code
- PPT
- Device Class
- Class II
- Regulation Number
- 882.4310
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253308 | materialise | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF T | January 7, 2026 |
| K201052 | kls-martin l.p | KLS Martin Individual Patient Solutions (IPS) Planning System | August 31, 2020 |
| K182889 | kls-martin l.p | KLS Martin Individual Patient Solutions (IPS) Planning System | July 26, 2019 |
| K151285 | 3d systems | VSP Cranial System | September 23, 2016 |