Identity Imprint Porous CR POV-012-4411

GUDID M572POV0124411011

POROUS OVAL PATELLA, 44MM X 11MM, iPoly

Conformis, Inc.

Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis
Primary Device IDM572POV0124411011
NIH Device Record Key6a369709-dd9c-4959-a68a-43d238559b8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdentity Imprint Porous CR
Version Model NumberPOV-012-4411-01
Catalog NumberPOV-012-4411
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 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

Device Dimensions

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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572POV0124411011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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 Date2023-09-18
Device Publish Date2023-09-08

On-Brand Devices [Identity Imprint Porous CR ]

M572TCR302T06S011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 6
M572TCR302T06N011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 6N
M572TCR302T05S011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 5
M572TCR302T05N011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 5N
M572TCR302T04S011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 4
M572TCR302T04N011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 4N
M572TCR302T03S011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 3
M572TCR302T03N011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 3N
M572TCR302T02S011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 2
M572TCR302T02N011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 2N
M572TCR302T01S011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 1
M572TCR102F07S011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 7 LEFT OR RIGHT
M572TCR102F06S011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 6 LEFT OR RIGHT
M572TCR102F06N011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 6N LEFT OR RIGHT
M572TCR102F05S011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 5 LEFT OR RIGHT
M572TCR102F05N011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 5N LEFT OR RIGHT
M572TCR102F04S011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 4 LEFT OR RIGHT
M572TCR102F04N011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 4N LEFT OR RIGHT
M572TCR102F03S011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 3 LEFT OR RIGHT
M572TCR102F03N011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 3N LEFT OR RIGHT
M572TCR102F02S011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 2 LEFT OR RIGHT
M572TCR102F02N011IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 2N LEFT OR RIGHT
M572TCR102F01S011POROUS CR FEMORAL IMPLANT SIZE 1 LEFT OR RIGHT
M572POV0124411011POROUS OVAL PATELLA, 44MM X 11MM, iPoly
M572POV0124110011POROUS OVAL PATELLA, 41MM X 10MM, iPoly
M572POV0123809011POROUS OVAL PATELLA, 38MM X 9MM, iPoly
M572POV0123509011POROUS OVAL PATELLA, 35MM X 9MM, iPoly
M572POV0123208011POROUS OVAL PATELLA, 32MM X 8MM, iPoly
M572TCR302T07S011IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 7
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