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Product codes
PPT
Product code PPT
Device name
Cranial Surgical Planning And Instrument Guides
Medical specialty
Neurology
Device class
2
Regulation number
882.4310
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset
Related 510(k) Records
#
510(k), Device, Applicant table
510(k)
Device
Applicant
Decision date
K253308
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
Materialise NV
2026-01-07
K201052
KLS Martin Individual Patient Solutions (IPS) Planning System
KLS-Martin L.P.
2020-08-31
K182889
KLS Martin Individual Patient Solutions (IPS) Planning System
KLS-Martin L.P.
2019-07-26
K151285
VSP Cranial System
3D Systems, Inc.
2016-09-23
Related GUDID Devices
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Published
00816847021081
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021340
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021333
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021326
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021319
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021302
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021296
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021289
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021272
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021265
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021210
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021180
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021173
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021142
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021111
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020688
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021050
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847021029
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020992
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020961
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020954
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020947
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020930
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020763
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020756
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020749
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020725
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020718
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020701
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12
00816847020695
VSP System, VSP Cranial
3D SYSTEMS, INC.
2016-09-12