iTotal Identity CR Knee Replacement System (with CS Insert) RCR-023-180N

GUDID M572RCR023180N011

ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 18MM, LEFT OR RIGHT

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 Tibial insert
Primary Device IDM572RCR023180N011
NIH Device Record Keyf447fe57-de4d-44b4-84df-d6d8c17f6a55
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal Identity CR Knee Replacement System (with CS Insert)
Version Model NumberRCR023180N01
Catalog NumberRCR-023-180N
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

Phone781-345-9001
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
HIBCCM572RCR023180N011 [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 Date2021-06-03
Device Publish Date2021-05-26

On-Brand Devices [iTotal Identity CR Knee Replacement System (with CS Insert)]

M572TCR023140J011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 14MM, LEFT OR RIGHT
M572TCR023130H011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 13MM, LEFT OR RIGHT
M572TCR023120G011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 12MM, LEFT OR RIGHT
M572TCR023110F011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 11MM, LEFT OR RIGHT
M572TCR023100E011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 10MM, LEFT OR RIGHT
M572TCR023090D011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 9MM, LEFT OR RIGHT
M572TCR023080C011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 8MM, LEFT OR RIGHT
M572TCR023070B011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 7MM, LEFT OR RIGHT
M572TCR023060A011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 6MM, LEFT OR RIGHT
M572TCR013140J011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 14MM, LEFT OR RIGHT
M572TCR013130H011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 13MM, LEFT OR RIGHT
M572TCR013120G011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 12MM, LEFT OR RIGHT
M572TCR013110F011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 11MM, LEFT OR RIGHT
M572TCR013100E011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 10MM, LEFT OR LEFT
M572TCR013090D011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 9MM, LEFT OR RIGHT
M572TCR013080C011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 8MM, LEFT OR RIGHT
M572TCR013070B011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 7MM, LEFT OR RIGHT
M572TCR013060A011ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 6MM, LEFT or RIGHT
M572RCR023080C011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 8MM, LEFT OR RIGHT
M572RCR023070B011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 7MM, LEFT OR RIGHT
M572RCR023060A011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 6MM, LEFT OR RIGHT
M572RCR013200R011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 20MM, LEFT OR RIGHT
M572RCR013190P011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 19MM, LEFT OR RIGHT
M572RCR013180N011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 18MM, LEFT OR RIGHT
M572RCR013170M011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 17MM, LEFT OR RIGHT
M572RCR013160L011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 16MM, LEFT OR RIGHT
M572RCR013150K011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 15MM, LEFT OR RIGHT
M572RCR013140J011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 14MM, LEFT OR RIGHT
M572RCR013130H011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 13MM, LEFT OR RIGHT
M572RCR013120G011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 12MM, LEFT OR RIGHT
M572RCR013110F011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 11MM, LEFT OR RIGHT
M572RCR013100E011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 10MM, LEFT OR RIGHT
M572RCR013090D011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 9MM, LEFT OR RIGHT
M572RCR013080C011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 8MM, LEFT OR RIGHT
M572RCR013070B011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 7MM, LEFT OR RIGHT
M572RCR013060A011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 6MM, LEFT OR RIGHT
M572RCR023200R011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 20MM, LEFT OR RIGHT
M572RCR023190P011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 19MM, LEFT OR RIGHT
M572RCR023180N011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 18MM, LEFT OR RIGHT
M572RCR023170M011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 17MM, LEFT OR RIGHT
M572RCR023160L011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 16MM, LEFT OR RIGHT
M572RCR023150K011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 15MM, LEFT OR RIGHT
M572RCR023140J011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 14MM, LEFT OR RIGHT
M572RCR023130H011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 13MM, LEFT OR RIGHT
M572RCR023120G011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 12MM, LEFT OR RIGHT
M572RCR023110F011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 11MM, LEFT OR RIGHT
M572RCR023100E011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 10MM, LEFT OR RIGHT
M572RCR023090D011ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 9MM, LEFT OR RIGHT
M572RCR013160L111ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, CS, SINGLE, 16MM, LEFT OR RIGHT
M572RCR013150K111ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, CS, SINGLE, 15MM, LEFT OR RIGHT

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