iTotal® Patella Trial

GUDID 00850268007095

iTotal® 32mm Patella Trial Reusable Instrument

Conformis, Inc.

Patella prosthesis trial
Primary Device ID00850268007095
NIH Device Record Key978fa045-b281-47b7-8578-8025deb11ef7
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal® Patella Trial
Version Model Number1080-510
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Outer Diameter32 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850268007095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850268007095]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-10-24

On-Brand Devices [iTotal® Patella Trial]

00850268007125iTotal® 41mm Patella Trial Reusable Instrument
00850268007118iTotal® 38mm Patella Trial Reusable Instrument
00850268007101iTotal® 35mm Patella Trial Reusable Instrument
00850268007095iTotal® 32mm Patella Trial Reusable Instrument
00850268007088iTotal® 29mm Patella Trial Reusable Instrument

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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