Home GUDID 00840097518770 Ossera™ AFX
Primary DI 00840097518770
Brand Ossera™ AFX
Company Restor3d, Inc.
Model 1744-4032-N
Device description Ossera™ AFX, Rectangle, 41x31x32
Published 2025-05-21
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true Product Codes# Code, Name table Code Name HSB Rod, Fixation, Intramedullary And Accessories SAI Ankle Fusion Cage
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSB Rod, Fixation, Intramedullary And Accessories Orthopedic 2 SAI Ankle Fusion Cage Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840097518770 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 00840097518770 00840097518770 840097518770 0840097518770
GMDN Terms# Term, Definition table Term Definition Metallic osteotomy fusion cage, non-customized A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080819836 Device count 1 Lot or batch 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 B058AHN08165L1 Atlas™ Humeral Nail System Orthopedic Designs North America, Inc. HSB 2026-05-29 B058AHN08165R1 Atlas™ Humeral Nail System Orthopedic Designs North America, Inc. HSB 2026-05-29 10855068008423 Lock Activator CURVAFIX, INC. HSB 2022-06-20 10855068008492 Inserter/Extractor CURVAFIX, INC. HSB 2022-06-20 10855068008539 Sterilization Case, Outer CURVAFIX, INC. HSB 2022-06-20 10855068008621 Ring Lock, Long Inserter CURVAFIX, INC. HSB 2022-06-20 10855068008003 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008010 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008027 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008034 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008041 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008058 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008065 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008072 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008089 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008096 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008102 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 07898624869669 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-21 07898624869140 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869157 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869164 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869171 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869188 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869195 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869201 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869218 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869225 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869232 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869249 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869256 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06