Definition: Intended To Redirect The Angle Of Growth Of Long Bone(s) Only In Pediatric Patients. Indicated For Temporary Or Permanent Epiphysiodesis. For Gradually Correcting Angular Deformities Of Long Bones In Pediatric Patients With An Open Physis. Specific C
| Device Type ID | 4655 |
| Device Name | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
| Physical State | Metallic Bone Fixation Appliances And Accessories |
| Technical Method | Mechanical Bone Fixation |
| Target Area | Long Bone Growth Plates Only. Spinal Indications Require Additional Testing, Labeling And An Different Product Code. |
| 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 | OBT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 4655 |
| Device | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
| Product Code | OBT |
| 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 | |
ORTHOFIX | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOFIX SRL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |