FDA.reportPublic FDA data

VSP Cranial

Primary DI
00816847021432
Brand
VSP Cranial
Company
3D SYSTEMS, INC.
Model
Cranial Cutting Guide
Device description
A physical template / guide that is positioned on patients’ anatomy (Bony), and allows for precise location of predetermined osteotomy planes and holes.
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPTCranial Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPTCranial Surgical Planning And Instrument GuidesNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151285000VSP Cranial System3D Systems, Inc.2016-09-23PPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816847021432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847021432008168470214328168470214320816847021432

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8446431001Golden-CustomerService@3DSystems.Com

Regulatory Flags#

DUNS number
085049749
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816847021487VSP OrthopedicsPatient Femur Cutting Guide2019-09-11
00816847021494VSP OrthopedicsPatient Femur Marking Guide2019-09-11
00816847021500VSP OrthopedicsPatient Femur Drilling Guide2019-09-11
00816847021517VSP OrthopedicsPatient Femur Template2019-09-11
00816847021524VSP OrthopedicsPatient Tibia Cutting Guide2019-09-11
00816847021531VSP OrthopedicsPatient Tibia Marking Guide2019-09-11
00816847021548VSP OrthopedicsPatient Tibia Drilling Guide2019-09-11
00816847021555VSP OrthopedicsPatient Tibia Template2019-09-11
00816847021562VSP OrthopedicsPatient Pelvic Cutting Guide2019-09-11
00816847021579VSP OrthopedicsPatient Pelvic Marking Guide2019-09-11
00816847021586VSP OrthopedicsPatient Pelvic Drilling Guide2019-09-11
00816847021593VSP OrthopedicsPatient Pelvic Template2019-09-11
00816847021807VSP OrthopedicsAllograft Femur Cutting Guide2019-09-11
00816847021814VSP OrthopedicsAllograft Femur Marking Guide2019-09-11
00816847021821VSP OrthopedicsAllograft Femur Drilling Guide2019-09-11
00816847021838VSP OrthopedicsAllograft Femur Template2019-09-11
00816847021845VSP OrthopedicsAllograft Tibia Cutting Guide2019-09-11
00816847021852VSP OrthopedicsAllograft Tibia Marking Guide2019-09-11
00816847021869VSP OrthopedicsAllograft Tibia Drilling Guide2019-09-11
00816847021876VSP OrthopedicsAllograft Tibia Template2019-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060350856TruMatch CMF Titanium 3D Printed GuidesMaterialise NVPPT2026-04-29
05420060351631TruMatch CMF Titanium 3D Printed GuidesMaterialise NVPPT2026-04-29
05420060351648TruMatch CMF Titanium 3D Printed GuidesMaterialise NVPPT2026-04-29
00888118144683IPSKLS-Martin L.P.PPT2024-10-08
00888118144720IPSKLS-Martin L.P.PPT2024-10-08
00888118140999IPSKLS-Martin L.P.PPT2023-03-22
00888118141002IPSKLS-Martin L.P.PPT2023-03-22
00888118141019IPSKLS-Martin L.P.PPT2023-03-22
00888118141026IPSKLS-Martin L.P.PPT2023-03-22
00888118141071IPSKLS-Martin L.P.PPT2023-03-22
00888118141088IPSKLS-Martin L.P.PPT2023-03-22
00888118141125IPSKLS-Martin L.P.PPT2023-03-22
00888118141163IPSKLS-Martin L.P.PPT2023-03-22
00888118141408IPSKLS-Martin L.P.PPT2023-03-22
00888118136190IPSKLS-Martin L.P.PPT2022-11-25
00888118136718IPSKLS-Martin L.P.PPT2022-11-25
00888118136725IPSKLS-Martin L.P.PPT2022-11-25
00888118136732IPSKLS-Martin L.P.PPT2022-11-25
00888118129260IPSKLS-Martin L.P.PPT2020-12-22
00888118129307IPSKLS-Martin L.P.PPT2020-12-22
00888118128867IPSKLS-Martin L.P.PPT2020-09-21
00888118128898IPSKLS-Martin L.P.PPT2020-09-21
00888118122681IPSKLS-Martin L.P.PPT2019-09-20
00888118122698IPSKLS-Martin L.P.PPT2019-09-20
00888118122704IPSKLS-Martin L.P.PPT2019-09-20
00888118122711IPSKLS-Martin L.P.PPT2019-09-20
00888118122728IPSKLS-Martin L.P.PPT2019-09-20
00888118122735IPSKLS-Martin L.P.PPT2019-09-20
00888118099952IPSKLS-Martin L.P.PPT2018-10-24
00816847021425VSP Cranial3D SYSTEMS, INC.PPT2016-10-12