Home GUDID B1132L2HB235100 Shoulder Innovations InSet FxR 135 Humeral Stem Trial
Primary DI B1132L2HB235100
Brand Shoulder Innovations InSet FxR 135 Humeral Stem Trial
Company Shoulder Innovations, Inc.
Model 10mmX135 Humeral Stem Trial
Catalog number 2L2HB23510
Device description Shoulder Innovations - InSet FxR 135 Humeral Stem Trial - 10mm
Published 2025-12-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented MBX Stimulator, Thalamic, Epilepsy, Implanted 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 KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic 2 KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic 2 MBX Stimulator, Thalamic, Epilepsy, Implanted Unknown 3 PHX Shoulder Prosthesis, Reverse Configuration Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B1132L2HB235100 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080404519 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B1132R2HC300100 Shoulder Innovations RSA Glenosphere Trial Instrument Case RSA Glenosphere Trial Instrument Case 2R2HC30010 2026-09-30 B1132N2GI200050 Shoulder Innovations InSet GO 20 mm x 5° 2N2GI20005 2026-09-18 B1132N2GI200100 Shoulder Innovations InSet GO 20 mm x 10° 2N2GI20010 2026-09-18 B1132N2GI206000 Shoulder Innovations InSet GO 20 mm x 6mm 2N2GI20600 2026-09-18 B1132N2GI208000 Shoulder Innovations InSet GO 20 mm x 8mm 2N2GI20800 2026-09-18 B1132N2GI220050 Shoulder Innovations InSet GO 22 mm x 5° 2N2GI22005 2026-09-18 B1132N2GI220100 Shoulder Innovations InSet GO 22 mm x 10° 2N2GI22010 2026-09-18 B1132N2GI226000 Shoulder Innovations InSet GO 22 mm x 6mm 2N2GI22600 2026-09-18 B1132N2GI228000 Shoulder Innovations InSet GO 22 mm x 8mm 2N2GI22800 2026-09-18 B1132N2GI240050 Shoulder Innovations InSet GO 24 mm x 5° 2N2GI24005 2026-09-18 B1132N2GI240100 Shoulder Innovations InSet GO 24 mm x 10° 2N2GI24010 2026-09-18 B1132N2GI246000 Shoulder Innovations InSet GO 24 mm x 6mm 2N2GI24600 2026-09-18 B1132N2GI248000 Shoulder Innovations InSet GO 24 mm x 8mm 2N2GI24800 2026-09-18 B1132N2GI270050 Shoulder Innovations InSet GO 27 mm x 5° 2N2GI27005 2026-09-18 B1132N2GI270100 Shoulder Innovations InSet GO 27 mm x 10° 2N2GI27010 2026-09-18 B1132N2GI276000 Shoulder Innovations InSet GO 27 mm x 6mm 2N2GI27600 2026-09-18 B1132N2GI278000 Shoulder Innovations InSet GO 27 mm x 8mm 2N2GI27800 2026-09-18 B1132A2HI000100 Shoulder Innovations InSet 95 Humeral Stem Low Profile Lever Lock Broach Handle 2A2HI00010 2026-05-28 B1130S1GK000030 Shoulder Innovations InSet 70 Humeral Stem K-Wire, 2.4mm x 90mm 0S1GK00003 2025-09-18 B1130S1GK000020 Shoulder Innovations Humeral Short Stem System K-Wire Guide 0S1GK00002 2023-11-28
Other Devices Sharing Product Codes# 
xx.xx