QRR
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3046
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CERAMENT G (K234008) | Bonesupport AB | 2024-03-13 |
| CERAMENT G (DEN210044) | Bonesupport AB | 2022-05-17 |
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Every clearance here is in the API, with alerts when new ones post.