Home GUDID 09348215137564 Origin TT Standard Offset Size 12
Primary DI 09348215137564
Brand Origin TT Standard Offset Size 12
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 59-0012
Published 2025-03-20
Public version status New
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 KWL Prosthesis, Hip, Hemi-, Femoral, Metal KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic 2 KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic 2 KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic 2 LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic 2 LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic 2 MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic 2 OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic 2 OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09348215137564 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215137564 09348215137564 9348215137564
GMDN Terms# Term, Definition table Term Definition Coated hip femur prosthesis, modular A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without 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 09348215019587 Evolve AP Cup - Size 28-40 111-17-4028 2026-06-26 09348215019594 Evolve AP Cup - Size 28-42 111-17-4228 2026-06-26 09348215019600 Evolve AP Cup - Size 28-44 111-17-4428 2026-06-26 09348215019617 Evolve AP Cup - Size 28-46 111-17-4628 2026-06-26 09348215019624 Evolve AP Cup - Size 28-48 111-17-4828 2026-06-26 09348215019631 Evolve AP Cup - Size 28-50 111-17-5028 2026-06-26 09348215019648 Evolve AP Cup - Size 28-52 111-17-5228 2026-06-26 09348215019655 Evolve AP Cup - Size 28-54 111-17-5428 2026-06-26 09348215019662 Evolve AP Cup - Size 28-56 111-17-5628 2026-06-26 09348215046019 World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mm 121-20-4120 2026-06-26 09348215046026 World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mm 121-20-4220 2026-06-26 09348215046033 World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mm 121-20-4320 2026-06-26 09348215046040 World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mm 121-20-4420 2026-06-26 09348215046057 World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mm 121-20-4520 2026-06-26 09348215046064 World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mm 121-20-4620 2026-06-26 09348215046071 World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mm 121-20-4720 2026-06-26 09348215046088 World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mm 121-20-4820 2026-06-26 09348215046095 World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mm 121-20-4920 2026-06-26 09348215148980 Evolve AP Vit-E Cup – Neutral - Size 32-46 111-17-0146 2026-06-26 09348215148997 Evolve AP Vit-E Cup – Neutral - Size 32-48 111-17-0148 2026-06-26
Other Devices Sharing Product Codes#