iTotal® PS Tibial Tray Kit RPS1011113

GUDID M572RPS1011113011

N/A

Conformis, Inc.

Total knee prosthesis implantation guide-instrument kit
Primary Device IDM572RPS1011113011
NIH Device Record Keyebf8d374-a087-4922-8b50-3776a17e2ccc
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal® PS Tibial Tray Kit
Version Model NumberRPS101111301
Catalog NumberRPS1011113
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
HIBCCM572RPS1011113011 [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

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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