Definition: The Hinged Internal Fixator Is Intended To Treat Joint Dislocations, More Specifically Of The Elbow Joint. The Device Is Intended To Be Removed Once Stability Is Achieved.
| Device Type ID | 4676 |
| Device Name | Internal Hinged Elbow Fixator |
| Physical State | The Hinged Internal Fixator Consists Of Titanium And Cobalt Chromium Components |
| Technical Method | The Hinged Internal Fixator Secures The Elbow Joint By Means Of A Plate And Screws On The Ulna Attached To A Pin That Is Inserted Into The Humerus. |
| Target Area | The Hinged Internal Fixator Is Intended For Use In The Elbow Joint. |
| 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 | OZI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4676 |
| Device | Internal Hinged Elbow Fixator |
| Product Code | OZI |
| 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 | |
SKELETAL DYNAMICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |