iDuo® iPoly™ Insert Kit RBK0101000

GUDID M572RBK0101000021

IDUO IPOLY 11MM INSERT KIT LEFT or right MEDIAL or lateral

Conformis, Inc.

Unicondylar knee insert
Primary Device IDM572RBK0101000021
NIH Device Record Keyd5e35ac5-a8f1-4db4-af68-9be707dcf40f
Commercial Distribution StatusIn Commercial Distribution
Brand NameiDuo® iPoly™ Insert Kit
Version Model NumberRBK010100002
Catalog NumberRBK0101000
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572RBK0101000021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPJProsthesis, Knee Patellofemorotibial, Partial, 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 Date2022-08-15
Device Publish Date2015-10-26

On-Brand Devices [iDuo® iPoly™ Insert Kit]

M572RBK0100700011N/A
M572RBK0101300021N/A
M572RBK0101100021IDUO IPOLY 11MM INSERT KIT LEFT or right MEDIAL or lateral
M572RBK0101000021IDUO IPOLY 11MM INSERT KIT LEFT or right MEDIAL or lateral
M572RBK0100700021IDUO–IPOLY–7MM INSERT KIT–LEFT or right MEDIAL or lateral
M572RBK0101200011N/A
M572RBK0101100011N/A
M572RBK0100900011N/A
M572RBK0100600011N/A

Trademark Results [iDuo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IDUO
IDUO
85794905 not registered Dead/Abandoned
i do it sarl
2012-12-05
IDUO
IDUO
85518103 4270942 Live/Registered
Liang, Hsien-Rong
2012-01-17
IDUO
IDUO
78652189 not registered Dead/Abandoned
Liang, Hsien-Rong
2005-06-16
IDUO
IDUO
77200574 3459154 Dead/Cancelled
ConforMIS, Inc.
2007-06-07
IDUO
IDUO
77087559 not registered Dead/Abandoned
I DO IT SPRLU
2007-01-22

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