510(k) DEN210044
DEN210044 is an FDA 510(k) premarket notification submitted by Bonesupport AB for the device "CERAMENT G". The FDA issued a decision of De Novo Granted on May 17, 2022. The device falls under product code QRR (Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside), a Class II device regulated under 21 CFR 888.3046. Bonesupport AB has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 17, 2022
- Date Received
- September 28, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
- Device Class
- Class II
- Regulation Number
- 888.3046
- Review Panel
- OR
- Submission Type
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.