Home GUDID 09348215054571 Origin Cemented Stem Standard Offset Size 9
Primary DI 09348215054571
Brand Origin Cemented Stem Standard Offset Size 9
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 111-42-0902
Published 2020-08-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09348215054571 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215054571 09348215054571 9348215054571
GMDN Terms# Term, Definition table Term Definition Uncoated femoral stem prosthesis, one-piece A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.
Regulatory Flags# DUNS number 751993028 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09348215010973 Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Left 10-1521-0302 2026-05-18 09348215010980 Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Right 10-1522-0322 2026-05-18 09348215010997 Active-V Knee Cementless CR Femoral Component - Size 1 - Left 10-1521-0303 2026-05-18 09348215011000 Active-V Knee Cementless CR Femoral Component - Size 1 - Right 10-1522-0323 2026-05-18 09348215011017 Active-V Knee Cementless CRFemoral Component - Size 2 Narrow - Left 10-1521-0304 2026-05-18 09348215011024 Active-V Knee Cementless CR Femoral Component - Size 2 Narrow - Right 10-1522-0324 2026-05-18 09348215011031 Active-V Knee Cementless CRFemoral Component - Size 2 - Left 10-1521-0305 2026-05-18 09348215011048 Active-V Knee Cementless CR Femoral Component - Size 2 - Right 10-1522-0325 2026-05-18 09348215011055 Active-V Knee Cementless CRFemoral Component - Size 3 Narrow - Left 10-1521-0306 2026-05-18 09348215011062 Active-V Knee Cementless CR Femoral Component - Size 3 Narrow - Right 10-1522-0326 2026-05-18 09348215011079 Active-V Knee Cementless CRFemoral Component - Size 3 - Left 10-1521-0307 2026-05-18 09348215011086 Active-V Knee Cementless CR Femoral Component - Size 3 - Right 10-1522-0327 2026-05-18 09348215011093 Active-V Knee Cementless CRFemoral Component - Size 4 Narrow - Left 10-1521-0308 2026-05-18 09348215011109 Active-V Knee Cementless CR Femoral Component - Size 4 Narrow - Right 10-1522-0328 2026-05-18 09348215011116 Active-V Knee Cementless CRFemoral Component - Size 4 - Left 10-1521-0309 2026-05-18 09348215011123 Active-V Knee Cementless CR Femoral Component - Size 4 - Right 10-1522-0329 2026-05-18 09348215011130 Active-V Knee Cementless CRFemoral Component - Size 5 Narrow - Left 10-1521-0210 2026-05-18 09348215011147 Active-V Knee Cementless CR Femoral Component - Size 5 Narrow - Right 10-1522-0230 2026-05-18 09348215014506 Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 1 Narrow 10-1513-0400 2026-05-18 09348215014513 Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 1 10-1513-0401 2026-05-18
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810030811992 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812036 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812043 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812050 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812067 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812074 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812081 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812098 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812104 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812111 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812128 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812135 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812142 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812159 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812173 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812180 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812197 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812203 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812210 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812227 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812234 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812241 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812258 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812265 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812272 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812289 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812296 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812319 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812326 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01 00810030812333 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC LZO 2026-06-01