| Primary Device ID | B973PREOPSHOULDER0 |
| NIH Device Record Key | 99c8612d-cfbc-46c8-a877-e6816f6314ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProVoyance PreOp Shoulder |
| Version Model Number | 2 |
| Company DUNS | 117655799 |
| Company Name | Genesis Software Innovations LLC |
| 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 |
| B973PREOPSHOULDER0 - ProVoyance PreOp Shoulder | 2024-06-10The PreOp Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source. 3D digital representations of various implant models are available in the planning software. Pre-Op Shoulder allows the user to digitally perform the surgical planning by showing a representation of the
patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy. The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Instructions for use can be found at the following location: https://portal.si.genesisplanningsoftware.com/ |
| B973PREOPSHOULDER0 - ProVoyance PreOp Shoulder | 2024-06-10 The PreOp Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans bas |
| B973PREVIEWSHOULDER0 - Preview | 2022-10-05 The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application wh |