Definition: Software Associated With An Orthopedic Trauma Device Which Is Intended For The Diagnosis Or Treatment Of Traumatic Or Reconstructive Orthopedic Conditions
| Device Type ID | 4669 |
| Device Name | Software For Diagnosis/treatment |
| Physical State | Custom Written Or Off The Shelf Software Intended To Be Used With An Orthopedic Trauma Device |
| Technical Method | Software Operated By The Manufacturer Or End User Intended To Diagnose Or Treat An Orthopedic Condition |
| Target Area | Musculoskeletal System |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4669 |
| Device | Software For Diagnosis/treatment |
| Product Code | OSN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| CFR Regulation Number | 888.3030 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ORTHOHUB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Computer Software Problem | 5 |
Break | 1 |
Output Problem | 1 |
Fitting Problem | 1 |
| Total Device Problems | 8 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Smith & Nephew, Inc. | II | Jan-08-2018 |