Definition: As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures.
| Device Type ID | 4678 |
| Device Name | Orthopaedic Surgical Planning And Instrument Guides |
| Physical State | Software And Hardware |
| Technical Method | For Pre-surgical Planning Including Transfering, Visualizing, Measuring, Annotating And Editing Medical Data. Patient Specific Templates That Are Based On Pre-operative Plan And Are Designed To Fit A Specific Patient. These Guides Are Used To Assist |
| Target Area | Long Bones |
| 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) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PBF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4678 |
| Device | Orthopaedic Surgical Planning And Instrument Guides |
| Product Code | PBF |
| 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 | |
MATERIALISE N.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |