Identity Imprint Knee Replacement System TPS-030-145N

GUDID M572TPS030145N011

PS TIBIAL INSERT TRIAL SIZE 5 NARROW 14MM LEFT AND RIGHT

Conformis, Inc.

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Primary Device IDM572TPS030145N011
NIH Device Record Keyc1ef1568-7d08-4172-b564-4ce352b180d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdentity Imprint Knee Replacement System
Version Model NumberTPS030145N01
Catalog NumberTPS-030-145N
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 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
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
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
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
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
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572TPS030145N011 [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 Date2021-06-18
Device Publish Date2021-06-10

On-Brand Devices [Identity Imprint Knee Replacement System]

M572TPS301T07S011PS TIBIAL TRAY SIZE 7
M572TPS301T06S011PS TIBIAL TRAY SIZE 6
M572TPS301T06N011PS TIBIAL TRAY SIZE 6 NARROW
M572TPS301T05S011PS TIBIAL TRAY SIZE 5
M572TPS301T05N011PS TIBIAL TRAY SIZE 5 NARROW
M572TPS301T04S011PS TIBIAL TRAY SIZE 4
M572TPS301T04N011PS TIBIAL TRAY SIZE 4 NARROW
M572TPS301T03S011PS TIBIAL TRAY SIZE 3
M572TPS301T03N011PS TIBIAL TRAY SIZE 3 NARROW
M572TPS301T02S011PS TIBIAL TRAY SIZE 2
M572TPS301T02N011PS TIBIAL TRAY SIZE 2 NARROW
M572TPS301T01S011PS TIBIAL TRAY SIZE 1
M572TPS101F07S011PS FEMORAL IMPLANT SIZE 7 LEFT or RIGHT
M572TPS101F06S011PS FEMORAL IMPLANT SIZE 6 LEFT or RIGHT
M572TPS101F06N011PS FEMORAL IMPLANT SIZE 6 NARROW LEFT or RIGHT
M572TPS101F05S011PS FEMORAL IMPLANT SIZE 5 LEFT or RIGHT
M572TPS101F05N011PS FEMORAL IMPLANT SIZE 5 NARROW LEFT or RIGHT
M572TPS101F04S011PS FEMORAL IMPLANT SIZE 4 LEFT or RIGHT
M572TPS101F04N011PS FEMORAL IMPLANT SIZE 4 Narrow LEFT or RIGHT
M572TPS101F03S011PS FEMORAL IMPLANT SIZE 3 LEFT or RIGHT
M572TPS101F03N011PS FEMORAL IMPLANT SIZE 3 Narrow LEFT or RIGHT
M572TPS101F02S011PS FEMORAL IMPLANT SIZE 2 LEFT or RIGHT
M572TPS101F02N011PS FEMORAL IMPLANT SIZE 2 Narrow LEFT or Right
M572TPS101F01S011PS FEMORAL IMPLANT SIZE 1 LEFT or Right
M572TCR301T07S011CR TIBIAL TRAY SIZE 7
M572TCR301T06S011CR TIBIAL TRAY SIZE 6
M572TCR301T06N01CR TIBIAL TRAY SIZE 6 NARROW
M572TCR301T05S011CR TIBIAL TRAY SIZE 5
M572TCR301T05N011CR TIBIAL TRAY SIZE 5 NARROW
M572TCR301T04S011CR TIBIAL TRAY SIZE 4
M572TCR301T04N011CR TIBIAL TRAY SIZE 4 NARROW
M572TCR301T03S011CR TIBIAL TRAY SIZE 3
M572TCR301T03N011CR TIBIAL TRAY SIZE 3 NARROW
M572TCR301T02S011CR TIBIAL TRAY SIZE 2
M572TCR301T02N011CR TIBIAL TRAY SIZE 2 NARROW
M572TCR301T01S011CR TIBIAL TRAY SIZE 1
M572TCR101F07S011CR FEMORAL IMPLANT SIZE 7 LEFT or Right
M572TCR101F06S011CR FEMORAL IMPLANT SIZE 6 LEFT or Right
M572TCR101F06N011CR FEMORAL IMPLANT SIZE 6 Narrow LEFT or Right
M572TCR101F05S011IDENTITY IMPRINT CR FEMORAL IMPLANT SIZE 5 LEFT or Right
M572TCR101F05N011CR FEMORAL IMPLANT SIZE 5 Narrow LEFT or Right
M572TCR101F04S011CR FEMORAL IMPLANT SIZE 4 LEFT or RIGHT
M572TCR101F04N011CR FEMORAL IMPLANT SIZE 4 Narrow LEFT or Right
M572TCR101F03S011CR FEMORAL IMPLANT SIZE 3 LEFT or Right
M572TCR101F03N011CR FEMORAL IMPLANT SIZE 3 Narrow LEFT or Right
M572TCR101F02S011CR FEMORAL IMPLANT SIZE 2 LEFT or Left
M572TCR101F02N011CR FEMORAL IMPLANT SIZE 2 Narrow LEFT or RIGHT
M572TCR101F01S011CR FEMORAL IMPLANT SIZE 1 LEFT or RIGHT
M572TCR020163N011CR TIBIAL INSERT SIZE 3 NARROW 16MM LEFT AND RIGHT
M572TCR020162S011CR TIBIAL INSERT SIZE 2 16MM LEFT AND RIGHT

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