Definition: BONE HETEROGRAFT IS A DEVICE INTENDED TO BE IMPLANTED THAT IS MADE FROM MATURE (ADULT) BOVINE BONES AND USED TO REPLACE HUMAN BONE FOLLOWING SURGERY IN THE CERVICAL REGION OF THE SPINAL COLUMN.
| Device Type ID | 4650 |
| Device Name | Bone, Heterograft |
| Regulation Description | Bone Heterograft. |
| 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 | PMA |
| CFR Regulation Number | 888.3015 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NVC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 4650 |
| Device | Bone, Heterograft |
| Product Code | NVC |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Bone Heterograft. |
| CFR Regulation Number | 888.3015 [🔎] |