kneeEOS

GUDID 03700757200506

kneeEOS allows surgeons to perform preoperative surgical planning of total knee arthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg.

ONEFIT MEDICAL

Orthopaedic/craniofacial implantation planning software
Primary Device ID03700757200506
NIH Device Record Key380c5e6f-ee9b-4156-992e-077c13c3a687
Commercial Distribution Discontinuation2020-05-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NamekneeEOS
Version Model Number1.0
Company DUNS263373588
Company NameONEFIT MEDICAL
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com
Phone+33381252427
Emailcontact@onefit-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103700757200506 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-02-02
Device Publish Date2016-10-11

Devices Manufactured by ONEFIT MEDICAL

03700757200506 - kneeEOS2021-02-02kneeEOS allows surgeons to perform preoperative surgical planning of total knee arthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg.
03700757200506 - kneeEOS2021-02-02 kneeEOS allows surgeons to perform preoperative surgical planning of total knee arthroplasties. The software provides surgical t
03700757200520 - hipEOS2021-02-02 hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regular
03700757200544 - spineEOS2021-02-02 spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis
03700757200643 - spineEOS rod Template2021-02-02 spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specifi
03700757200650 - spineEOS rod Template2021-02-02 spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specifi
03700757200759 - spineEOS rod Template2021-02-02 spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specifi
03700757200766 - spineEOS rod Template2021-02-02 spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specifi
03700757200773 - spineEOS rod Template2021-02-02 spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specifi

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