PPT
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cranial Surgical Planning And Instrument Guides
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4310
- Medical specialty
- Neurology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (K253308) | Materialise NV | 2026-01-07 |
| KLS Martin Individual Patient Solutions (IPS) Planning System (K201052) | KLS-Martin L.P. | 2020-08-31 |
| KLS Martin Individual Patient Solutions (IPS) Planning System (K182889) | KLS-Martin L.P. | 2019-07-26 |
| VSP Cranial System (K151285) | 3D Systems, Inc. | 2016-09-23 |
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Every clearance here is in the API, with alerts when new ones post.