Home GUDID 00840097509938 restor3d Kinos Axiom PSR
Primary DI 00840097509938
Brand restor3d Kinos Axiom PSR
Company Restor3d, Inc.
Model 5831-9005
Device description Kinos Axiom Coupled PSR, Chamfer-cut
Published 2023-09-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name OYK Ankle Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OYK Ankle Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840097509938 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840097509938 00840097509938 840097509938 0840097509938
GMDN Terms# Term, Definition table Term Definition Osteotomy guide, single-use A 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 single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080819836 Device count 1 Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841731147431 OPTIX VILEX LLC OYK 2026-03-03 00816847022736 Salto Talaris Flat Cut Total Ankle System 3D SYSTEMS, INC. OYK 2025-01-10 00816847022743 Salto Talaris Flat Cut Total Ankle System 3D SYSTEMS, INC. OYK 2025-01-10 00816847022750 Salto Talaris Flat Cut Total Ankle System 3D SYSTEMS, INC. OYK 2025-01-10 00816847022767 Cadence Flat Cut Total Ankle System 3D SYSTEMS, INC. OYK 2025-01-10 00816847022774 Cadence Flat Cut Total Ankle System 3D SYSTEMS, INC. OYK 2025-01-10 00816847022781 Cadence Flat Cut Total Ankle System 3D SYSTEMS, INC. OYK 2025-01-10 00816847022637 Cadence Chamfer Cut Total Ankle System 3D SYSTEMS, INC. OYK 2024-09-12 00816847022651 Salto Talaris Chamfer Cut Total Ankle System 3D SYSTEMS, INC. OYK 2024-09-12 00816847022699 Salto Talaris Chamfer Cut Total Ankle System 3D SYSTEMS, INC. OYK 2024-09-12 00816847022705 Salto Talaris Chamfer Cut Total Ankle System 3D SYSTEMS, INC. OYK 2024-09-12 00816847022712 Cadence Chamfer Cut Total Ankle System 3D SYSTEMS, INC. OYK 2024-09-12 00816847022729 Cadence Chamfer Cut Total Ankle System 3D SYSTEMS, INC. OYK 2024-09-12 00816847022798 Vantage 3D PSI 3D SYSTEMS, INC. OYK 2024-08-05 00816847022804 Vantage 3D PSI 3D SYSTEMS, INC. OYK 2024-08-05 00816847022811 Vantage 3D PSI 3D SYSTEMS, INC. OYK 2024-08-05 00816847022828 Vantage 3D+ PSI 3D SYSTEMS, INC. OYK 2024-08-05 00816847022835 Vantage 3D+ PSI 3D SYSTEMS, INC. OYK 2024-08-05 00816847022842 Vantage 3D+ PSI 3D SYSTEMS, INC. OYK 2024-08-05 00840097509914 restor3d Kinos Axiom PSR Restor3d, Inc. OYK 2023-09-27 00840097509921 restor3d Kinos Axiom PSR Restor3d, Inc. OYK 2023-09-27 00840097509945 restor3d Kinos Axiom PSR Restor3d, Inc. OYK 2023-09-27 00840097508924 restor3d Kinos Axiom PSR Restor3d, Inc. OYK 2023-05-01 00840097508931 restor3d Kinos Axiom PSR Restor3d, Inc. OYK 2023-05-01 00840097508948 restor3d Kinos Axiom PSR Restor3d, Inc. OYK 2023-05-01 00840097508955 restor3d Kinos Axiom PSR Restor3d, Inc. OYK 2023-05-01 00816847022576 Vantage PSI 3D SYSTEMS, INC. OYK 2020-11-13 00816847022606 Vantage PSI 3D SYSTEMS, INC. OYK 2020-11-13 00816847022583 Vantage PSI 3D SYSTEMS, INC. OYK 2020-11-13 00816847022590 Vantage PSI 3D SYSTEMS, INC. OYK 2020-11-13