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510(k) K253308

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models by Materialise NV — Product Code PPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2026
Date Received
September 29, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cranial Surgical Planning And Instrument Guides
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type

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.

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Other clearances for product code PPT

  • K201052 — KLS Martin Individual Patient Solutions (IPS) Planning System (August 31, 2020)
  • K182889 — KLS Martin Individual Patient Solutions (IPS) Planning System (July 26, 2019)
  • K151285 — VSP Cranial System (September 23, 2016)