Definition: Anterior Cervical Device For Supplemental Fixation To Support A Fusion.
| Device Type ID | 4682 |
| Device Name | Anterior Staple As Supplemental Fixation For Fusion |
| Physical State | This Is A Metalic Staple That Is Implanted Into Two Adjacent Vertebral Bodies. |
| Technical Method | The Staple Provides Physical Support While A Fusion Develops Between Vertebral Bodies. |
| Target Area | This Is Intended For The Anterior, Cervical Spinal Column In Skeletally Mature Patients. |
| Regulation Description | Spinal Intervertebral Body Fixation Orthosis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Anterior Spine Devices Branch (ASDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3060 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4682 |
| Device | Anterior Staple As Supplemental Fixation For Fusion |
| Product Code | PHQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Spinal Intervertebral Body Fixation Orthosis. |
| CFR Regulation Number | 888.3060 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDICREA INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |