Home GUDID 03701037317907 FX V 135 stem
Primary DI 03701037317907
Brand FX V 135 stem
Company FX SOLUTIONS
Model 318-5212
Catalog number 318-5212
Device description FX V135 STEM TA6V Ø32/12 LG 120MM CEMENTLESS Ti/HA
Published 2023-06-15
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented PHX Shoulder Prosthesis, Reverse Configuration
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic 2 KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic 2 PHX Shoulder Prosthesis, Reverse Configuration Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03701037317907 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03701037317907 03701037317907 3701037317907
GMDN Terms# Term, Definition table Term Definition Coated shoulder humeral stem prosthesis A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
Regulatory Flags# DUNS number 263076196 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 03701037313855 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 961-0017 961-0017 2026-06-26 03701037315897 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-8803 951-8803 2026-06-26 03701037315903 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-8806 951-8806 2026-06-26 03701037315910 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-8809 951-8809 2026-06-26 03701037315927 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-8812 951-8812 2026-06-26 03701037315934 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-8815 951-8815 2026-06-26 03701037315941 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-8818 951-8818 2026-06-26 03701037315958 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-9803 951-9803 2026-06-26 03701037315965 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-9806 951-9806 2026-06-26 03701037315972 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-9809 951-9809 2026-06-26 03701037315989 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-9812 951-9812 2026-06-26 03701037315996 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-9815 951-9815 2026-06-26 03701037316009 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-9818 951-9818 2026-06-26 03701037316535 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-9909 951-9909 2026-06-26 03701037316542 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-9912 951-9912 2026-06-26 03701037316559 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-9915 951-9915 2026-06-26 03701037316566 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-9918 951-9918 2026-06-26 03701037300718 HUMELOCK 903-4036 903-4036 2026-06-25 03701037307007 Humelock II Cementless Shoulder System 926-1025 926-1025 2026-06-25 03701037307984 HUMELOCK 903-4440 903-4440 2026-06-25
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