iTotal® CR iPoly XE™ Insert Kit RCR020000H

GUDID M572RCR020000H011

N/A

Conformis, Inc.

Total knee prosthesis implantation guide-instrument kit
Primary Device IDM572RCR020000H011
NIH Device Record Keyb3a446fc-f048-427d-867e-2fb6d935d327
Commercial Distribution Discontinuation2022-08-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameiTotal® CR iPoly XE™ Insert Kit
Version Model NumberRCR020000H01
Catalog NumberRCR020000H
Company DUNS808821883
Company NameConformis, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

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
HIBCCM572RCR020000H011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-08-16
Device Publish Date2015-10-26

On-Brand Devices [iTotal® CR iPoly XE™ Insert Kit]

M572RCR0201600011N/A
M572RCR0201500011N/A
M572RCR0201400011N/A
M572RCR0201300011N/A
M572RCR0201200011N/A
M572RCR0201100011N/A
M572RCR0201000011N/A
M572RCR0200900011N/A
M572RCR0200800011N/A
M572RCR0200700011N/A
M572RCR0200600011N/A
M572RCR020000K011N/A
M572RCR020000J011N/A
M572RCR020000I011N/A
M572RCR020000H011N/A
M572RCR020000G011N/A
M572RCR020000F011N/A
M572RCR020000E011N/A
M572RCR020000D011N/A
M572RCR020000C011N/A
M572RCR020000B011N/A
M572RCR020000A011N/A

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.