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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
ONEFIT MEDICAL
KIT0706
Not in Commercial Distribution

  • 03700757200780 ()
/

  • Surgical implant template, single-use
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.
ONEFIT MEDICAL
KIT0705
Not in Commercial Distribution

  • 03700757200773 ()
/

  • Surgical implant template, single-use
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.
ONEFIT MEDICAL
KIT0702
Not in Commercial Distribution

  • 03700757200650 ()
/

  • Surgical implant template, single-use
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.
ONEFIT MEDICAL
KIT0701
Not in Commercial Distribution

  • 03700757200643 ()
/

  • Surgical implant template, single-use
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.
ONEFIT MEDICAL
1.1
Not in Commercial Distribution

  • 03700757200544 ()


  • Orthopaedic/craniofacial implantation planning software
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
2.5
Not in Commercial Distribution

  • 03700757200520 ()


  • Orthopaedic/craniofacial implantation planning software
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.
ONEFIT MEDICAL
1.0
Not in Commercial Distribution

  • 03700757200506 ()


  • Orthopaedic/craniofacial implantation planning software
No Description
EOS IMAGING
3.2
Not in Commercial Distribution

  • 03663999000177 ()


  • Orthopaedic/craniofacial implantation planning software
No Description
EOS IMAGING
1.2
Not in Commercial Distribution

  • 03663999000160 ()


  • Orthopaedic/craniofacial implantation planning software
No Description
EOS IMAGING
2.1
In Commercial Distribution

  • 03663999000108 ()


  • Stationary basic diagnostic x-ray system, digital
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