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510(k) K151285

VSP Cranial System by 3D Systems, Inc. — Product Code PPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2016
Date Received
May 14, 2015
Clearance Type
Traditional
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

  • K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF T (January 7, 2026)
  • K201052 — KLS Martin Individual Patient Solutions (IPS) Planning System (August 31, 2020)
  • K182889 — KLS Martin Individual Patient Solutions (IPS) Planning System (July 26, 2019)