iTotal® CR Tibial Tray Kit RCR1011113

GUDID M572RCR1011113011

N/A

Conformis, Inc.

Uncoated knee tibia prosthesis, metallic
Primary Device IDM572RCR1011113011
NIH Device Record Keyb12d3e35-df09-4949-914a-d64b3efae9b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal® CR Tibial Tray Kit
Version Model NumberRCR101111301
Catalog NumberRCR1011113
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572RCR1011113011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOGKnee Arthroplasty Implantation System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-10-26

On-Brand Devices [iTotal® CR Tibial Tray Kit]

M572RCR1011113031N/A
M572RCR1011113021N/A
M572RCR1011113011N/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.