IDENTITY IMPRINT TCR-033-062N

GUDID M572TCR033062N011

IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 2N 6MM LEFT OR RIGHT

Conformis, Inc.

Joint prosthesis implantation kit, single-use
Primary Device IDM572TCR033062N011
NIH Device Record Key43a78abf-2a70-4cd6-bbe5-cb423711feb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDENTITY IMPRINT
Version Model NumberTCR-033-062N-01
Catalog NumberTCR-033-062N
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572TCR033062N011 [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 Date2023-07-24
Device Publish Date2023-07-14

On-Brand Devices [IDENTITY IMPRINT]

M572TCR033186S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 6 18MM LEFT AND RIGHT
M572TCR033186N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 6N 18MM LEFT AND RIGHT
M572TCR033185S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 5 18MM LEFT AND RIGHT
M572TCR033185N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 5N 18MM LEFT AND RIGHT
M572TCR033184S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 4 18MM LEFT AND RIGHT
M572TCR033184N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 4N 18MM LEFT AND RIGHT
M572TCR033183S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 3 18MM LEFT AND RIGHT
M572TCR033183N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 3N 18MM LEFT AND RIGHT
M572TCR033182S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 2 18MM LEFT AND RIGHT
M572TCR033182N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 2N 18MM LEFT OR RIGHT
M572TCR033181S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 1 18MM LEFT OR RIGHT
M572TCR033167S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 7 16MM LEFT AND RIGHT
M572TCR033166S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 6 16MM LEFT AND RIGHT
M572TCR033166N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 6N 16MM LEFT AND RIGHT
M572TCR033165S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 5 16MM LEFT AND RIGHT
M572TCR033165N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 5N 16MM LEFT AND RIGHT
M572TCR033164S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 4 16MM LEFT AND RIGHT
M572TCR033164N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 4N 16MM LEFT AND RIGHT
M572TCR033163S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 3 16MM LEFT AND RIGHT
M572TCR033163N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 3N 16MM LEFT AND RIGHT
M572TCR033162S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 2 16MM LEFT AND RIGHT
M572TCR033162N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 2N 16MM LEFT AND RIGHT
M572TCR033161S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 1 16MM LEFT OR RIGHT
M572TCR033147S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 7 14MM LEFT AND RIGHT
M572TCR033146S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 6 14MM LEFT AND RIGHT
M572TCR033146N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 6N 14MM LEFT AND RIGHT
M572TCR033145S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 5 14MM LEFT AND RIGHT
M572TCR033145N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 5N 14MM LEFT AND RIGHT
M572TCR033144S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 4 14MM LEFT AND RIGHT
M572TCR033144N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 4N 14MM LEFT AND RIGHT
M572TCR033143S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 3 14MM LEFT AND RIGHT
M572TCR033143N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 3N 14MM LEFT AND RIGHT
M572TCR033142S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 2 14MM LEFT AND RIGHT
M572TCR033142N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 2N 14MM LEFT OR RIGHT
M572TCR033141S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 1 14MM LEFT OR RIGHT
M572TCR033127S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 7 12MM LEFT AND RIGHT
M572TCR033126S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 6 12MM LEFT AND RIGHT
M572TCR033126N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 6N 12MM LEFT AND RIGHT
M572TCR033125S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 5 12MM LEFT AND RIGHT
M572TCR033125N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 5N 12MM LEFT AND RIGHT
M572TCR033124S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 4 12MM LEFT AND RIGHT
M572TCR033124N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 4N 12MM LEFT AND RIGHT
M572TCR033123S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 3 12MM LEFT AND RIGHT
M572TCR033123N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 3N 12MM LEFT AND RIGHT
M572TCR033122S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 2 12MM LEFT AND RIGHT
M572TCR033122N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 2N 12MM LEFT OR RIGHT
M572TCR033121S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 1 12MM LEFT OR RIGHT
M572TCR033107S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 7 10MM LEFT AND RIGHT
M572TCR033106S011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 6 10MM LEFT AND RIGHT
M572TCR033106N011IDENTITY IMPRINT CS TIBIAL INSERT TRIAL SIZE 6N 10MM LEFT AND RIGHT

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