iTotal® iPoly XE™ Patella PAT0213206

GUDID M572PAT0213206011

N/A

Conformis, Inc.

Polyethylene patella prosthesis
Primary Device IDM572PAT0213206011
NIH Device Record Keyc0b0f343-d35a-4c95-b94d-ffbf4407ca12
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal® iPoly XE™ Patella
Version Model NumberPAT021320601
Catalog NumberPAT0213206
Company DUNS808821883
Company NameConformis, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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

Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572PAT0213206011 [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 Date2021-02-05
Device Publish Date2015-10-26

On-Brand Devices [iTotal® iPoly XE™ Patella]

M572PAT0214110011N/A
M572PAT0213808011N/A
M572PAT0213507011N/A
M572PAT0213206011N/A
M572PAT0212906011N/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.