Home GUDID 05397283000441 Pro-X1
Primary DI 05397283000441
Brand Pro-X1
Company X-BOLT ORTHOPEDICS INC.
Model XBT105115
Device description 115mm x Ø10.5mm Trochanteric X-Bolt and Set-Screw
Published 2024-08-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Sterile true
Single use true Product Codes# Code, Name table Code Name HSB Rod, Fixation, Intramedullary And Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSB Rod, Fixation, Intramedullary And Accessories Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05397283000441 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05397283000441 05397283000441 5397283000441
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone screw (non-sliding) A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).
Device Sizes# Type, Value, Unit table Type Value Unit Length 115 Millimeter
Regulatory Flags# DUNS number 119116284 Device count 1 Lot or batch true Manufacturing date on label 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 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