Home GUDID M572HES03412UH011 ACTERA
Primary DI M572HES03412UH011
Brand ACTERA
Company Conformis, Inc.
Model HES-034-12UH-01
Catalog number HES-034-12UH
Device description FEMORAL HIP STEM UNCOLLARED SZ 12, HIGH OFFSET
Published 2023-06-26
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 MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class 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
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M572HES03412UH011 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Coated femoral stem prosthesis, one-piece A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is 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 808821883 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810933031114 Cordera Hip System Offset Cup Impactor, Enztec 1080-646 1080-646 2022-03-07 00810933031183 Cordera Hip System Radel Liner Impactors 28mm 1080-655 1080-655 2022-03-07 00810933031190 Cordera Hip System Radel Liner Impactors 32mm 1080-656 1080-656 2022-03-07 00810933031206 Cordera Hip System Radel Liner Impactors 36mm 1080-657 1080-657 2022-03-07 00810933031213 Cordera Hip System Radel Liner Impactors 40mm 1080-658 1080-658 2022-03-07 00810933031220 Cordera Hip System T-handle Quick Connect 1080-659 1080-659 2022-03-07 00810933031237 Cordera Hip System OrthoGroup Cup Impactor 1080-660 1080-660 2022-03-07 00850268007187 iTotal® Impactor Head 1080-541 2016-10-24 00850268007194 iTotal® Impactor Head 1080-535 2016-10-24 00850268007200 iTotal® CR Tibial Tray Impactor Tip 1080-536 2016-10-24 00850268007217 iTotal® PS Tibial Tray Impactor Tip 1080-542 2016-10-24 00850268007224 iTotal® Poly Impactor Tip 1080-524 2016-10-24 M572HDL060C24S011 iTotal® Hip Replacement System HDL060C24S01 HDL060C24S 2018-08-06 M572HDL060D24S011 iTotal® Hip Replacement System HDL060D24S01 HDL060D24S 2018-07-30 M572HDL060D34S011 iTotal® Hip Replacement System HDL060D34S01 HDL060D34S 2018-08-06 M572HDL060E24S011 iTotal® Hip Replacement System HDL060E24S01 HDL060E24S 2018-08-06 M572HDL060E34S011 iTotal® Hip Replacement System HDL060E34S01 HDL060E34S 2018-08-06 M572HDL060F24S011 iTotal® Hip Replacement System HDL060F24S01 HDL060F24S 2018-08-06 M572HDL060F34S011 iTotal® Hip Replacement System HDL060F34S01 HDL060F34S 2018-08-06 M572HDL060C10S011 iTotal® Hip Replacement System HDL060C10S01 HDL060C10S 2018-08-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07611996142334 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142365 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142372 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142389 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142396 POLARSTEM Smith & Nephew, Inc. MEH 2016-09-01 07611996103410 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103434 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103489 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103496 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103502 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103519 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103533 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103540 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996152692 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103373 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-22 07611996103380 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-22 07611996103397 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-22 07611996103403 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-22 07613153071273 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071280 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071297 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071310 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071327 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071334 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071341 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071358 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071365 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071372 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071396 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071402 Restoration Howmedica Osteonics Corp. MEH 2015-09-24
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