| DeNovo ID | DEN210044 |
| Device Name: | CERAMENT G |
| Classification | Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside |
| Applicant | BoneSupport AB scheelevagen 19, Ideon Science Park Lund, SE Se 223-70 |
| Contact | Blerta Shuka |
| Product Code | QRR |
| CFR Regulation Number | 888.3046 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Orthopedic |
| Classification Advisory | Orthopedic |
| Type | Direct |
| Date Received | 2021-09-28 |
| Decision Date | 2022-05-17 |
| Reclassification Order: | Reclassification Order |