Definition: Intended For Defining Orthopedic Acetabular Implant Alignment Relative To A Patient's Anatomy.
| Device Type ID | 4459 |
| Device Name | Patient Specific Manual Orthopedic Stereotaxic System |
| Physical State | Manual Instrument And Auxiliary Software. |
| Technical Method | Pre-operative Imagery, Such As CT Or Radiographs, Is Used To Establish A Correlation Between The Patient's AP Plane And The Instrument¿s Plane. |
| Target Area | Acetabulum |
| Regulation Description | Stereotaxic Instrument. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4459 |
| Device | Patient Specific Manual Orthopedic Stereotaxic System |
| Product Code | OSF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stereotaxic Instrument. |
| CFR Regulation Number | 882.4560 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Materialise N.V. | II | Oct-23-2015 |