Home GUDID 09348215017316 Signature BiPolar Head
Primary DI 09348215017316
Brand Signature BiPolar Head
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 111-21-2241
Published 2018-04-30
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 KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09348215017316 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215017316 09348215017316 9348215017316
GMDN Terms# Term, Definition table Term Definition Bipolar femoral head outer component, hemiarthroplasty An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.
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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850011453476 REMEDY CoCr Modular Heads OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453483 REMEDY CoCr Modular Heads OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453490 REMEDY CoCr Modular Heads OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453506 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453513 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453520 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWY 2026-06-01 07611996118674 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142327 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142334 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142341 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142358 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142365 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142372 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142389 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996074901 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074918 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074925 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074956 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074963 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074987 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996075021 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095586 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095593 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095616 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095630 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095647 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19