DEN210044 is an FDA 510(k) submission for the CERAMENT G. This device is classified as a Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside (Class II - Special Controls, product code QRR).
Submitted by Bonesupport AB (Lund, SE). The FDA issued a Not Cleared (DENG) decision on May 17, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3046. 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..
| 510(k) Number | DEN210044 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 28, 2021 |
| Decision Date | May 17, 2022 |
| Days to Decision | 231 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QRR - Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3046 |
| 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. |