kneeEOS - kneeEOS allows surgeons to perform preoperative - ONEFIT MEDICAL

Duns Number:263373588

Device Description: kneeEOS allows surgeons to perform preoperative surgical planning of total kneearthroplast kneeEOS allows surgeons to perform preoperative surgical planning of total kneearthroplasties. 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.

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More Product Details

Catalog Number

-

Brand Name

kneeEOS

Version/Model Number

1.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 27, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

380c5e6f-ee9b-4156-992e-077c13c3a687

Public Version Date

February 02, 2021

Public Version Number

5

DI Record Publish Date

October 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ONEFIT MEDICAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 6