FDA.reportPublic FDA data

VSP PEEK

Primary DI
00816847022675
Brand
VSP PEEK
Company
3D SYSTEMS, INC.
Model
Cranial Implant
Device description
to fill a bony void or defect area in the cranial skeleton of patients
Published
2024-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
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
00816847022675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847022675008168470226758168470226750816847022675

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
085049749
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816847022859VSP PEEKHost Skull Model2025-11-10
00816847022736Salto Talaris Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022750Salto Talaris Flat Cut Total Ankle SystemAnatomical Model2025-01-10
00816847022767Cadence Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022774Cadence Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022781Cadence Flat Cut Total Ankle SystemAnatomical model2025-01-10
00816847022637Cadence Chamfer Cut Total Ankle SystemAnatomical model2024-09-12
00816847022651Salto Talaris Chamfer Cut Total Ankle SystemAnatomical Model2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022798Vantage 3D PSITibia Cutting Guide2024-08-05
00816847022804Vantage 3D PSITalus Cutting Guide2024-08-05
00816847022811Vantage 3D PSIAnatomical Model2024-08-05
00816847022828Vantage 3D+ PSITibia Cutting Guide2024-08-05
00816847022835Vantage 3D+ PSITalus Cutting Guide2024-08-05
00816847022842Vantage 3D+ PSIAnatomical Model2024-08-05
00816847022576Vantage PSITalus Cutting Guide351-80-002020-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810125929823CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929830FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929847CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929854CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929687CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929694CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929700CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929717FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929724CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929731CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929748FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929755CUSTOMIZED CRANIOFACIAL IMPLANT (CCI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929663CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929670FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929625CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929632CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929649CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01