Primary Device ID | M572HAR000S263011 |
NIH Device Record Key | 29216d0d-523c-4296-8f86-7c4d77ae3679 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | iTotal® Hip Replacement System |
Version Model Number | HAR000S26301 |
Catalog Number | HAR000S263 |
Company DUNS | 808821883 |
Company Name | Conformis, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 781-345-9001 |
customer-service@conformis.com | |
Phone | 781-345-9001 |
customer-service@conformis.com | |
Phone | 781-345-9001 |
customer-service@conformis.com | |
Phone | 781-345-9001 |
customer-service@conformis.com | |
Phone | 781-345-9001 |
customer-service@conformis.com | |
Phone | 781-345-9001 |
customer-service@conformis.com | |
Phone | 781-345-9001 |
customer-service@conformis.com | |
Phone | 781-345-9001 |
customer-service@conformis.com | |
Phone | 781-345-9001 |
customer-service@conformis.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M572HAR000S263011 [Primary] |
OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2022-08-15 |
Device Publish Date | 2018-08-29 |
M572HAH01036XL011 | N/A |
M572HAH01036SH011 | N/A |
M572HAH01036MD011 | N/A |
M572HAH01036LG011 | N/A |
M572HAH01032XL011 | N/A |
M572HAH01032SH011 | N/A |
M572HAH01032MD011 | N/A |
M572HAH01032LG011 | N/A |
M572HAH01028XL011 | N/A |
M572HAH01028SH011 | N/A |
M572HAH01028MD011 | N/A |
M572HAH01028LG011 | N/A |
M572HAH04040XL011 | N/A |
M572HAH04040SH011 | N/A |
M572HAH04040MD011 | N/A |
M572HAH04040LG011 | N/A |
M572HAH04036XL011 | N/A |
M572HAH04036SH011 | N/A |
M572HAH04036MD011 | N/A |
M572HAH04036LG011 | N/A |
M572HAH04032XL011 | N/A |
M572HAH04032SH011 | N/A |
M572HAH04032MD011 | N/A |
M572HAH04032LG011 | N/A |
M572HAH04028SH011 | N/A |
M572HAH04028MD011 | N/A |
M572HAH04028LG011 | N/A |
M572HDL060F34S011 | HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +4 STD |
M572HDL060F32S011 | HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +2 STD (PLN) |
M572HDL060F32L011 | HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +2 LIP |
M572HDL060F32F011 | HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +2 FC |
M572HDL060F30S011 | HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 STD |
M572HDL060F30L011 | HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 LIP |
M572HDL060F30F011 | HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 FC |
M572HDL060F24S011 | HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +4 STD |
M572HDL060F22S011 | HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +2 STD (PLN) |
M572HDL060F22L011 | HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +2 LIP |
M572HDL060F22F011 | HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +2 FC |
M572HDL060F20S011 | HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +0 STD |
M572HDL060F20L011 | HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +0 LIP |
M572HDL060F20F011 | HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +0 FC |
M572HDL060E34S011 | HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +4 STD |
M572HDL060E32S011 | HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +2 STD (PLN) |
M572HDL060E32L011 | HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +2 LIP |
M572HDL060E32F011 | HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +2 FC |
M572HDL060E30S011 | HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 STD |
M572HDL060E30L011 | HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 LIP |
M572HDL060E30F011 | HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 FC |
M572HDL060E24S011 | HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +4 STD |
M572HDL060E22S011 | HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +2 STD (PLN) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ITOTAL 79337466 not registered Live/Pending |
TOTAL JUGGLING S.r.l 2021-10-06 |
![]() ITOTAL 77519937 4006512 Live/Registered |
ConforMIS, Inc. 2008-07-11 |
![]() ITOTAL 77200561 not registered Dead/Abandoned |
ConforMIS, Inc. 2007-06-07 |
![]() ITOTAL 76133213 2498210 Dead/Cancelled |
ConnecTotal Staffing, Inc. 2000-09-22 |