Home GUDID 00816127029523 InSitu Hip System
Primary DI 00816127029523
Brand InSitu Hip System
Company NEXTSTEP ARTHROPEDIX, LLC
Model 10-22-0056
Device description Bipolar Head Assembly, Size 56mm
Published 2023-08-18
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 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 00816127029523 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816127029523 00816127029523 816127029523 0816127029523
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 060211165 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# 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
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