Cranial Surgical Planning And Instrument Guides
Neurology · 21 CFR 882.4310
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 MDR events
0 adverse event reports on file
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Event type breakdown
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Recalls
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Registered firms
11 firms currently registered for this product code
Materialise N.v.
LEUVEN Vlaams Brabant, BE
Kls-martin L.p.
Jacksonville, FL, US
Medical Modeling - A 3d Systems Company
Littleton, CO, US
Materialise Colombia S.a.s
Medellin Antioquia, CO
Materialise Usa, Llc.
Plymouth, MI, US
Materialise Sdn Bhd
Petaling Jaya Selangor, MY
Materialise Ukraine, Rep. Office
Kyiv Kyyiv, Misto, UA
Kls Martin Manufacturing, Llc
Jacksonville, FL, US
Kls Martin Se & Co. Kg
Muhlheim/Donau Baden-Wurttemberg, DE
510(k) clearances
4 clearances for this product code
- Materialise NVJan 7, 2026
K253308 · Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
- KLS-Martin L.P.Aug 31, 2020
K201052 · KLS Martin Individual Patient Solutions (IPS) Planning System
- KLS-Martin L.P.Jul 26, 2019
K182889 · KLS Martin Individual Patient Solutions (IPS) Planning System
- 3D Systems, Inc.Sep 23, 2016
K151285 · VSP Cranial System