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hipEOS

FDA UDI

Class II (US FDA UDI)

by Onefit Medical

Identity

Trade Name
hipEOS FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Device Name
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. FDA UDI
Model / Reference
3.x FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
03700757200834 FDA UDI
510(k) Number
K173390 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Orthopaedic/craniofacial implantation planning software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic/craniofacial implantation planning software

hipEOS by Onefit Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic/craniofacial implantation planning software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Onefit Medical

Sources (1)

  • FDA UDI 0db8b0eb-801c-4342-8aa1-74f1dd5bac6f 35 fields · synced May 30, 2026