| Primary Device ID | 03700757200544 |
| NIH Device Record Key | 3130167f-4a1e-4766-9fe9-71669d1e597e |
| Commercial Distribution Discontinuation | 2017-06-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | spineEOS |
| Version Model Number | 1.1 |
| Company DUNS | 263373588 |
| Company Name | ONEFIT MEDICAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 03700757200506 - kneeEOS | 2021-02-02 kneeEOS allows surgeons to perform preoperative surgical planning of total knee
arthroplasties. The software provides surgical t |
| 03700757200520 - hipEOS | 2021-02-02 hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regular |
| 03700757200544 - spineEOS | 2021-02-02spineEOS 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. |
| 03700757200544 - spineEOS | 2021-02-02 spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis |
| 03700757200643 - spineEOS rod Template | 2021-02-02 spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specifi |
| 03700757200650 - spineEOS rod Template | 2021-02-02 spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specifi |
| 03700757200759 - spineEOS rod Template | 2021-02-02 spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specifi |
| 03700757200766 - spineEOS rod Template | 2021-02-02 spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specifi |
| 03700757200773 - spineEOS rod Template | 2021-02-02 spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specifi |