hipEOS

GUDID 03700757200520

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.

ONEFIT MEDICAL

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• Primary Device ID: 03700757200520
• NIH Device Record Key: ce12f059-96ca-4921-93ea-cf334143ecb9
• Commercial Distribution Discontinuation: 2019-10-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: hipEOS
• Version Model Number: 2.5
• Company DUNS: 263373588
• Company Name: ONEFIT MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com
• Phone: +381252427
• Email: contact@onefit-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700757200520 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-02
• Device Publish Date: 2016-09-26

On-Brand Devices [hipEOS]

• 03700757200827: hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The progr
• 03700757200520: hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The progr