OIS
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NORIAN DRILLABLE (K073303) | Synthes (Usa) | 2008-07-02 |
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