Definition: To Fill Traumatic Or Surgically-created Defects Not Intrinsic To The Stability Of The Bony Structure. It Is Delivered To The Defect And Resorbs Over Time To Be Replaced By Bone. Not For Screw Augmentation.
| Device Type ID | 4659 |
| Device Name | Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation |
| Physical State | Bone Void Filler And Mixing And Delivery System |
| Technical Method | Placed Or Injected In Bony Defects |
| Target Area | Various, Specified Bone Voids (e.g., Extremeties, Pelvis) |
| Regulation Description | Resorbable Calcium Salt Bone Void Filler Device. |
| 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 | 888.3045 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OIS |
| 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 | 4659 |
| Device | Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation |
| Product Code | OIS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Resorbable Calcium Salt Bone Void Filler Device. |
| CFR Regulation Number | 888.3045 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes USA | II | Feb-15-2018 |