FDA.reportPublic FDA data

VSP PEEK

Primary DI
00816847022859
Brand
VSP PEEK
Company
3D SYSTEMS, INC.
Model
Host Skull Model
Device description
provided as a guide , to determine the orientation and examine the fitment of the implant on the cranial defect prior to surgery
Published
2025-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWOPlate, Cranioplasty, Preformed, Alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231834000VSP PEEK Cranial Implant3D Systems, Inc.2024-04-04GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816847022859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847022859008168470228598168470228590816847022859

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, non-alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Regulatory Flags#

DUNS number
085049749
Device count
1
Lot or batch
true
Manufacturing date on label
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
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00810228570144FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570151CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570168CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570175FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570182FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-08-17
00810125929991CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570007FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570014FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570021FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570038CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570045FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570052CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570069CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570076CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570083CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
00810228570090FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
00810125929892CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929908FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929915CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929922CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929939CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929946CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929953CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929960CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929977CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929984CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929861CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929878CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929885CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06