Home GUDID 10603295172437 S-ROM
Primary DI 10603295172437
Brand S-ROM
Company DEPUY ORTHOPAEDICS, INC.
Model 53-5306
Catalog number 535306
Device description S-ROM Modular Hip System SPA Proximal Sleeve POROUS COATED 20 F FITS: 20 x 15 STEM Cone: F
Published 2015-03-24
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 JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate MRA Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic 2 KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic 2 LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic 2 LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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 MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10603295172437 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10603295172437 10603295172437
GMDN Terms# Term, Definition table Term Definition Sleeve femoral/tibial extension, coated A sterile implantable device typically designed to be attached to a revision femoral stem, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to make up for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included.
Regulatory Flags# DUNS number 080506581 Device count 1 Lot or batch 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 07611996074901 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074901 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074918 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074918 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074925 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074925 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074956 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074956 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074963 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074963 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074970 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074970 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074970 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074987 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074987 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996075007 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075007 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996075007 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996075021 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075021 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19 07611996075038 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075038 SL-PLUS Smith & Nephew, Inc. JDI 2016-08-19
xx.xx