hipEOS - hipEOS allows surgeons to perform pre-operative - ONEFIT MEDICAL

Duns Number:263373588

Device Description: hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

hipEOS

Version/Model Number

2.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2019

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

ce12f059-96ca-4921-93ea-cf334143ecb9

Public Version Date

February 02, 2021

Public Version Number

4

DI Record Publish Date

September 26, 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