Cleared Traditional

VSP Cranial System

K151285 · 3D Systems, Inc. · Neurology

Sep 2016

Decision

498d

Days

Class 2

Risk

About This 510(k) Submission

K151285 is an FDA 510(k) clearance for the VSP Cranial System, a Cranial Surgical Planning And Instrument Guides (Class II — Special Controls, product code PPT), submitted by 3D Systems, Inc. (Golden, US). The FDA issued a Cleared decision on September 23, 2016, 498 days after receiving the submission on May 14, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K151285 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2015
Decision Date	September 23, 2016
Days to Decision	498 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PPT — Cranial Surgical Planning And Instrument Guides
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4310
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.