Home GUDID 00822409130603 Balanced Knee Revision System
Primary DI 00822409130603
Brand Balanced Knee Revision System
Company Ortho Development Corporation
Model 561-0520
Device description Sleeve Junction Box
Published 2024-11-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER MBH PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2 MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00822409130603 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 00822409130603 00822409130603 822409130603 0822409130603
GMDN Terms# Term, Definition table Term Definition Knee femur stem prosthesis A sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.
Regulatory Flags# DUNS number 876542390 Device count 1 DM exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840097536705 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536781 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536798 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536804 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536804 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536811 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536811 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 E31442411410 Signature Materialise NV JWH 2026-09-24 E31442411410 Signature Materialise NV MBH 2026-09-24 E31442422415 Signature Materialise NV JWH 2026-09-24 E31442422415 Signature Materialise NV MBH 2026-09-24 E31442422450 Signature Materialise NV MBH 2026-09-24 E31442422450 Signature Materialise NV JWH 2026-09-24 E31442422451 Signature Materialise NV JWH 2026-09-24 E31442422451 Signature Materialise NV MBH 2026-09-24 E31442422452 Signature Materialise NV JWH 2026-09-24 E31442422452 Signature Materialise NV MBH 2026-09-24
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