FDA.reportPublic FDA data

Vantage PSI

Primary DI
00816847022583
Brand
Vantage PSI
Company
3D SYSTEMS, INC.
Model
Tibia Cutting Guide
Catalog number
351-80-10
Device description
A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
Published
2020-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OYKAnkle Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYKAnkle Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193432000Vantage PSI System3D Systems2020-11-09OYK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816847022583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847022583008168470225838168470225830816847022583

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter

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
Lot or batch
true
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
00841731147431OPTIXVILEX LLCOYK2026-03-03
00816847022736Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022750Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022767Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022774Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022781Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022637Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022651Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022798Vantage 3D PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022804Vantage 3D PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022811Vantage 3D PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022828Vantage 3D+ PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022835Vantage 3D+ PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022842Vantage 3D+ PSI3D SYSTEMS, INC.OYK2024-08-05
00840097509914restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097509921restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097509938restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097509945restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097508924restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00840097508931restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00840097508948restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00840097508955restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00816847022576Vantage PSI3D SYSTEMS, INC.OYK2020-11-13
00816847022606Vantage PSI3D SYSTEMS, INC.OYK2020-11-13
00816847022590Vantage PSI3D SYSTEMS, INC.OYK2020-11-13