Home GUDID B1130S1GK00020 SHOULDER INNOVATIONS TSA SYSTEM
Primary DI B1130S1GK00020
Brand SHOULDER INNOVATIONS TSA SYSTEM
Company Shoulder Innovations, Inc.
Model K WIRE
Catalog number 0S1GK0002
Published 2018-06-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use 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
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
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B1130S1GK00020 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation 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. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface 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 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 B1132N1HG000000 Shoulder Innovations Humeral Short Stem System K-Wire Guide 2N1HG00000 2023-10-03 B1132N1IA000010 Shoulder Innovations Humeral Short Stem System K-Wire 1.6mm 2N1IA00001 2023-10-03 B1132G1HB300010 Shoulder Innovations Humeral Stemless System Stemless Broach - Minus 2G1HB30001 2026-05-04 B1132G1HB300020 Shoulder Innovations Humeral Stemless System Stemless Broach - Standard 2G1HB30002 2026-05-04 B1132R1NET20360 Shoulder Innovations Inset Reverse Total Shoulder N22 Eccentric EZ Glenosphere - 36mm Diameter x 2mm 2R1NET2036 2026-01-19 B1132R1NET30390 Shoulder Innovations Inset Reverse Total Shoulder N22 Eccentric EZ Glenosphere - 39mm Diameter x 3mm 2R1NET3039 2026-01-19 B1132R1NET40420 Shoulder Innovations Inset Reverse Total Shoulder N22 Eccentric EZ Glenosphere - 42mm Diameter x 4mm 2R1NET4042 2026-01-19 B1132R1NLT03330 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 33mm Diameter x 0 2R1NLT0333 2026-01-19 B1132R1NLT03360 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 36mm Diameter x 0 2R1NLT0336 2026-01-19 B1132R1NLT03390 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 39mm Diameter x 0 2R1NLT0339 2026-01-19 B1132R1NLT03420 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 42mm Diameter x 0 2R1NLT0342 2026-01-19 B1132R1NLT06330 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 33mm Diameter x 0 2R1NLT0633 2026-01-19 B1132R1NLT06360 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 36mm Diameter x 0 2R1NLT0636 2026-01-19 B1132R1NLT06390 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 39mm Diameter x 0 2R1NLT0639 2026-01-19 B1132R1NLT06420 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 42mm Diameter x 0 2R1NLT0642 2026-01-19 B1132R1NST00330 Shoulder Innovations Inset Reverse Total Shoulder N22 Standard EZ Glenosphere - 33mm Diameter x 0mm 2R1NST0033 2026-01-19 B1132R1NST00360 Shoulder Innovations Inset Reverse Total Shoulder N22 Standard EZ Glenosphere - 36mm Diameter x 0mm 2R1NST0036 2026-01-19
Other Devices Sharing Product Codes# 
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