Home GUDID 00816127028434 iNSitu™ Hip System
Primary DI 00816127028434
Brand iNSitu™ Hip System
Company NEXTSTEP ARTHROPEDIX, LLC
Model 10-13-0016
Device description Dual Tapered, Femoral Stem, Size 16, Standard
Published 2023-09-14
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 LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 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 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 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 00816127028434 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 00816127028434 00816127028434 816127028434 0816127028434
GMDN Terms# Term, Definition table Term Definition Coated femoral stem prosthesis, modular A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically 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 and implantation may be performed with or without bone cement.
Regulatory Flags# DUNS number 060211165 Device count 1 DM exempt true 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 00816127025518 TheRay Collared and Collarless Femoral Stem 12-12-0000 2025-09-02 00816127025525 TheRay Collared and Collarless Femoral Stem 12-12-0001 2025-09-02 00816127025532 TheRay Collared and Collarless Femoral Stem 12-12-0002 2025-09-02 00816127025549 TheRay Collared and Collarless Femoral Stem 12-12-0003 2025-09-02 00816127025556 TheRay Collared and Collarless Femoral Stem 12-12-0004 2025-09-02 00816127025563 TheRay Collared and Collarless Femoral Stem 12-12-0005 2025-09-02 00816127025570 TheRay Collared and Collarless Femoral Stem 12-12-0006 2025-09-02 00816127025587 TheRay Collared and Collarless Femoral Stem 12-12-0007 2025-09-02 00816127025594 TheRay Collared and Collarless Femoral Stem 12-12-0008 2025-09-02 00816127025600 TheRay Collared and Collarless Femoral Stem 12-12-0009 2025-09-02 00816127025617 TheRay Collared and Collarless Femoral Stem 12-12-0010 2025-09-02 00816127025648 TheRay Collared and Collarless Femoral Stem 12-13-0000 2025-09-02 00816127025655 TheRay Collared and Collarless Femoral Stem 12-13-0001 2025-09-02 00816127025662 TheRay Collared and Collarless Femoral Stem 12-13-0002 2025-09-02 00816127025679 TheRay Collared and Collarless Femoral Stem 12-13-0003 2025-09-02 00816127025686 TheRay Collared and Collarless Femoral Stem 12-13-0004 2025-09-02 00816127025693 TheRay Collared and Collarless Femoral Stem 12-13-0005 2025-09-02 00816127025709 TheRay Collared and Collarless Femoral Stem 12-13-0006 2025-09-02 00816127025716 TheRay Collared and Collarless Femoral Stem 12-13-0007 2025-09-02 00816127025723 TheRay Collared and Collarless Femoral Stem 12-13-0008 2025-09-02
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07611996118674 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142327 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142341 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142358 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142365 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142389 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142396 POLARSTEM Smith & Nephew, Inc. LZO 2016-09-01 07611996074918 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074963 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074970 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075007 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075021 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075038 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095586 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095593 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095609 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095616 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095623 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095630 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095647 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095654 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095661 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095678 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095685 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996103410 POLARSTEM Smith & Nephew, Inc. LZO 2016-07-25 07611996103427 POLARSTEM Smith & Nephew, Inc. LZO 2016-07-25
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