iTotal Identity Posterior Stabilized Knee Replacement System RPS0100700

GUDID M572RPS0100700131

ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 7MM

Conformis, Inc.

Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert
Primary Device IDM572RPS0100700131
NIH Device Record Key353ba919-588e-4c23-8b7f-28aa07ea7083
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal Identity Posterior Stabilized Knee Replacement System
Version Model NumberRPS010070013
Catalog NumberRPS0100700
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 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

Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com
Phone781-345-0001
Emailcustomer-service@conformis.com

Device Dimensions

Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572RPS0100700131 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-10
Device Publish Date2020-07-02

On-Brand Devices [iTotal Identity Posterior Stabilized Knee Replacement System]

M572TPS0201200011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 12MM, RIGHT
M572TPS0201100011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 11MM, RIGHT
M572TPS0201000011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 10MM
M572TPS0200900011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 9MM
M572TPS0200800011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 8MM
M572TPS0200700011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 7MM
M572TPS0200600011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 6MM
M572TPS0101300011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY, 13MM
M572TPS0201400011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 14MM
M572TPS0201300011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 13MM
M572RPS0102000131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 20MM
M572RPS0101900131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 19MM
M572RPS0101800131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 18MM
M572RPS0101700131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 17MM
M572RPS0101600131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 16MM
M572RPS0101500131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 15MM
M572RPS0101400131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 14MM
M572RPS0101300131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 13MM
M572RPS0101200131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 12MM
M572RPS0101100131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 11MM
M572RPS0101000131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 10MM
M572RPS0100900131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 9MM
M572RPS0100800131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 8MM
M572RPS0100700131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 7MM
M572RPS0100600131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 6MM
M572RPS0202200131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 22MM
M572RPS0202100131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 21MM
M572RPS0202000131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 20MM
M572RPS0201900131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 19MM
M572RPS0201800131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 18MM
M572RPS0201700131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 17MM
M572RPS0201600131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 16MM
M572RPS0201500131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 15MM
M572RPS0201400131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 14MM
M572RPS0201300131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 13MM
M572RPS0201200131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 12MM
M572RPS0201100131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 11MM
M572RPS0201000131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 10MM
M572RPS0200900131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 9MM
M572RPS0200800131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 8MM
M572RPS0200700131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 7MM
M572RPS0200700031ITOTAL IDENTITY PS TIBIAL INSERT + TRIAL, IPOLY XE, 7MM, RIGHT
M572RPS0200600131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 6MM
M572RPS0200600031ITOTAL IDENTITY PS TIBIAL INSERT + TRIAL, IPOLY XE, 6MM, RIGHT
M572RPS0102200131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 22MM
M572RPS0102100131ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 21MM
M572TPS3011113011ITOTAL IDENTITY PS TIBIAL TRAY, (TITANIUM, CEMENTED)
M572TPS1011112011ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMENTED)
M572TPS0100800011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY, 8MM
M572TPS0100700011ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY, 7MM

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