K234008 is an FDA 510(k) clearance 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 Cleared decision on March 13, 2024, 85 days after receiving the submission on December 19, 2023.
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 | K234008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2023 |
| Decision Date | March 13, 2024 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| 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. |