iTotal® Hip Replacement System HAH04040XL

GUDID M572HAH04040XL011

N/A

Conformis, Inc.

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis
Primary Device IDM572HAH04040XL011
NIH Device Record Keyc2f8a235-7742-4264-9668-9f64368d4c53
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal® Hip Replacement System
Version Model NumberHAH04040XL01
Catalog NumberHAH04040XL
Company DUNS808821883
Company NameConformis, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572HAH04040XL011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-09-09
Device Publish Date2018-08-06

On-Brand Devices [iTotal® Hip Replacement System]

M572HAH01036XL011N/A
M572HAH01036SH011N/A
M572HAH01036MD011N/A
M572HAH01036LG011N/A
M572HAH01032XL011N/A
M572HAH01032SH011N/A
M572HAH01032MD011N/A
M572HAH01032LG011N/A
M572HAH01028XL011N/A
M572HAH01028SH011N/A
M572HAH01028MD011N/A
M572HAH01028LG011N/A
M572HAH04040XL011N/A
M572HAH04040SH011N/A
M572HAH04040MD011N/A
M572HAH04040LG011N/A
M572HAH04036XL011N/A
M572HAH04036SH011N/A
M572HAH04036MD011N/A
M572HAH04036LG011N/A
M572HAH04032XL011N/A
M572HAH04032SH011N/A
M572HAH04032MD011N/A
M572HAH04032LG011N/A
M572HAH04028SH011N/A
M572HAH04028MD011N/A
M572HAH04028LG011N/A
M572HDL060F34S011HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +4 STD
M572HDL060F32S011HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +2 STD (PLN)
M572HDL060F32L011HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +2 LIP
M572HDL060F32F011HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +2 FC
M572HDL060F30S011HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 STD
M572HDL060F30L011HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 LIP
M572HDL060F30F011HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 FC
M572HDL060F24S011HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +4 STD
M572HDL060F22S011HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +2 STD (PLN)
M572HDL060F22L011HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +2 LIP
M572HDL060F22F011HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +2 FC
M572HDL060F20S011HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +0 STD
M572HDL060F20L011HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +0 LIP
M572HDL060F20F011HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +0 FC
M572HDL060E34S011HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +4 STD
M572HDL060E32S011HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +2 STD (PLN)
M572HDL060E32L011HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +2 LIP
M572HDL060E32F011HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +2 FC
M572HDL060E30S011HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 STD
M572HDL060E30L011HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 LIP
M572HDL060E30F011HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 FC
M572HDL060E24S011HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +4 STD
M572HDL060E22S011HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +2 STD (PLN)

Trademark Results [iTotal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ITOTAL
ITOTAL
79337466 not registered Live/Pending
TOTAL JUGGLING S.r.l
2021-10-06
ITOTAL
ITOTAL
77519937 4006512 Live/Registered
ConforMIS, Inc.
2008-07-11
ITOTAL
ITOTAL
77200561 not registered Dead/Abandoned
ConforMIS, Inc.
2007-06-07
ITOTAL
ITOTAL
76133213 2498210 Dead/Cancelled
ConnecTotal Staffing, Inc.
2000-09-22

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