Definition: Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia.
| Device Type ID | 4685 |
| Device Name | Bone Wedge |
| Physical State | Wedge With Or Without Graft Window Made Of Metal Or Polymer |
| Technical Method | A Wedge That May Act As A Spacer And/or Hold Bone Graft In Opening Wedge Osteotomy Procedures, Column Lengthening, Or Fusion |
| Target Area | Foot, Ankle, Proximal Tibia |
| 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 Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4685 |
| Device | Bone Wedge |
| Product Code | PLF |
| 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 | |
PARAGON 28 | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TYBER MEDICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arthrex, Inc. | II | Jun-14-2016 |