onefit-medical.comHipEOS
OneFIT Medical
ONEFIT MEDICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010966699 | 3010966699 | ONEFIT MEDICAL | 1 | N | 2020-04-25 | 18 rue Alain Savary BESANCON Doubs FR 25000 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03700757200506 | kneeEOS - kneeEOS allows surgeons to perform preoperative surgical planning of total kneearthroplasties. 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. | +33381252427 | contact@onefit-medical.com |
| 03700757200520 | hipEOS - 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. | +381252427 | contact@onefit-medical.com |
| 03700757200544 | spineEOS - spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | +33381252427 | contact@onefit-medical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 172026 | 1568041636 | K173390 | hipEOS | LLZ | 2018-04-27 |
| 172026 | 1468420581 | K161828 | kneeEOS | LLZ | 2016-10-03 |
| 172026 | 1539539016 | K160407 | spineEOS | LLZ | 2016-04-08 |
| 172026 | 1407763190 | K142671 | ONEFIT HIP PLANNER | LLZ | 2014-12-05 |
| 172026 | 1422233812 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LLZ | 4 | 2018-04-27 |
PMN#
GUDID#
kneeEOS - kneeEOS allows surgeons to perform preoperative surgical planning of total kneearthroplasties. 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.
2016-10-11
hipEOS - 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.
2016-09-26
spineEOS - spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies.
2016-09-26
spineEOS rod Template - spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
2017-02-23
spineEOS rod Template - spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
2017-02-23
spineEOS rod Template - spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
2017-02-23
spineEOS rod Template - spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
2017-02-23
spineEOS rod Template - spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
2017-02-23
spineEOS rod Template - spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
2017-02-23
spineEOS rod Template - spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
2017-02-23
spineEOS rod Template - spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his
2017-02-23
hipEOS - 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.
2017-02-13
hipEOS - 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.
2018-05-24
spineEOS - spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies.
2017-06-27