FDA.reportPublic FDA data

hipEOS

Primary DI
03700757200834
Brand
hipEOS
Company
ONEFIT MEDICAL
Model
3.x
Device 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.
Published
2018-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173390000hipEOSOnefit Medical2018-04-27LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700757200834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700757200834037007572008343700757200834

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Contacts#

Phone, Email table
PhoneEmail
+33381252427contact@onefit-medical.com

Regulatory Flags#

DUNS number
263373588
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700757200506kneeEOS1.02016-10-11
03700757200520hipEOS2.52016-09-26
03700757200544spineEOS1.12016-09-26
03700757200643spineEOS rod TemplateKIT0701/2017-02-23
03700757200650spineEOS rod TemplateKIT0702/2017-02-23
03700757200759spineEOS rod TemplateKIT0703/2017-02-23
03700757200766spineEOS rod TemplateKIT0704/2017-02-23
03700757200773spineEOS rod TemplateKIT0705/2017-02-23
03700757200780spineEOS rod TemplateKIT0706/2017-02-23
03700757200797spineEOS rod TemplateKIT0707/2017-02-23
03700757200803spineEOS rod TemplateKIT0708/2017-02-23
03700757200827hipEOS2.x/2017-02-13
03700757200858spineEOS1.x2017-06-27

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Primary DI, Brand, Company table
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