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510(k) K151285

Device
VSP Cranial System
Applicant
3D Systems, Inc.
510(k) number
K151285
Product code
PPT  
Decision
Substantially Equivalent (SESE)
Decision date
2016-09-23
Date received
2015-05-14
Regulation
882.4310
Classification name
Cranial Surgical Planning And Instrument Guides
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kim Torluemke
Address
17301 W. Colfax Ave. Suite 300 Golden CO US 80401 80401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PPT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsMaterialise NV2026-01-07
K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.2020-08-31
K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.2019-07-26

Legacy Summary#

summary

FDA Review#

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