iTotal® CR Tibial Tray Impactor Tip

GUDID 00850268007200

iTotal® CR Tibial Tray Impactor Tip Reusable Instrument

Conformis, Inc.

Orthopaedic implant impactor
Primary Device ID00850268007200
NIH Device Record Key5b7aea25-74aa-46b7-80e6-7761b4a152ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal® CR Tibial Tray Impactor Tip
Version Model Number1080-536
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

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100850268007200 [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

[00850268007200]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-24

Devices Manufactured by Conformis, Inc.

M572TCR000D00F021 - Identity Imprint CR Knee Replacement System2024-07-04 CR FEMORAL INSTRUMENTS,ALL SIZES LEFT AND RIGHT
M572TCR000D00T021 - Identity Imprint CR Knee Replacement System2024-07-04 CR TIBIAL INSTRUMENTS ALL SIZES LEFT OR RIGHT
M572TPS000D00F021 - Identity Imprint PS Knee Replacement System2024-07-04 PS Femoral INSTRUMENTS,ALL SIZES LEFT AND RIGHT
M572TCR302T07S011 - Identity Imprint Porous CR 2024-02-01 IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 7
00810933031817 - Calcar Planer Adapter Drop-in2023-12-13 Calcar Planer Adapter Drop-in ED-09733
M572POV0123208011 - Identity Imprint Porous CR 2023-09-18 POROUS OVAL PATELLA, 32MM X 8MM, iPoly
M572POV0123509011 - Identity Imprint Porous CR 2023-09-18 POROUS OVAL PATELLA, 35MM X 9MM, iPoly
M572POV0123809011 - Identity Imprint Porous CR 2023-09-18 POROUS OVAL PATELLA, 38MM X 9MM, iPoly

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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