iTotal® CR iPoly® XE Insert Kit RCR0201600

GUDID M572RCR0201600131

ITOTAL CR IPOLY XE 16MM MEDIAL INSERT KIT LEFT or right NO TRIAL

Conformis, Inc.

Tibial insert
Primary Device IDM572RCR0201600131
NIH Device Record Key9d312e67-3789-48ba-b9f2-00b45d84d900
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal® CR iPoly® XE Insert Kit
Version Model NumberRCR020160013
Catalog NumberRCR0201600
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

Device Dimensions

Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572RCR0201600131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-08-15
Device Publish Date2018-04-27

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

M572RCR0201600131ITOTAL CR IPOLY XE 16MM MEDIAL INSERT KIT LEFT or right NO TRIAL
M572RCR0201500131ITOTAL CR IPOLY XE 15MM MEDIAL INSERT KIT LEFT or right NO TRIAL
M572RCR0201400131ITOTAL CR IPOLY XE 14MM MEDIAL INSERT KIT RIGHT NO TRIAL
M572RCR0201300131ITOTAL CR IPOLY XE 13MM MEDIAL INSERT KIT LEFT or right NO TRIAL
M572RCR0201200131ITOTAL CR IPOLY XE 12MM MEDIAL INSERT KIT left or RIGHT NO TRIAL
M572RCR0201100131ITOTAL CR IPOLY XE 11MM MEDIAL INSERT KIT LEFT or right NO TRIAL
M572RCR0201000131ITOTAL CR IPOLY XE 10MM MEDIAL INSERT KIT LEFT or right NO TRIAL
M572RCR0200900131ITOTAL CR IPOLY XE 9MM MEDIAL INSERT KIT LEFT or right NO TRIAL
M572RCR0200800131ITOTAL CR IPOLY XE 8MM MEDIAL INSERT KIT LEFT or right NO TRIAL
M572RCR0200600131ITOTAL CR IPOLY XE 6MM MEDIAL INSERT KIT LEFT or right NO TRIAL
M572RCR020000K131ITOTAL CR IPOLY XE LATERAL K INSERT KIT LEFT or right NO TRIAL
M572RCR020000I131ITOTAL CR IPOLY XE LATERAL I INSERT KIT LEFT or right NO TRIAL
M572RCR020000G131ITOTAL CR IPOLY XE LATERAL G INSERT KIT LEFT or right NO TRIAL
M572RCR020000F131ITOTAL CR IPOLY XE LATERAL F INSERT KIT LEFT or right NO TRIAL
M572RCR020000E131ITOTAL CR IPOLY XE LATERAL E INSERT KIT LEFT NO TRIAL
M572RCR020000D131ITOTAL CR IPOLY XE LATERAL D INSERT KIT LEFT NO TRIAL
M572RCR020000B131ITOTAL CR IPOLY XE LATERAL B INSERT KIT LEFT or right NO TRIAL
M572RCR020000A131ITOTAL CR IPOLY XE LATERAL A INSERT KIT LEFT NO TRIAL
M572RCR020000H131N/A
M572RCR020000J131ITOTAL CR IPOLY XE LATERAL J INSERT KIT LEFT or right NO TRIAL

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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