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kneeEOS

FDA UDI

Class II (US FDA UDI)

by Onefit Medical

Identity

Trade Name
kneeEOS FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Device Name
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. FDA UDI
Model / Reference
1.0 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
03700757200506 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
Not 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Onefit Medical

Sources (1)

  • FDA UDI 380c5e6f-ee9b-4156-992e-077c13c3a687 35 fields · synced May 30, 2026