510(k) DEN210044
- Device
- CERAMENT G
- Applicant
- Bonesupport AB
- 510(k) number
- DEN210044
- Product code
- QRR
- Decision
- Unknown (DENG)
- Decision date
- 2022-05-17
- Date received
- 2021-09-28
- Regulation
- 888.3046
- Classification name
- Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Blerta Shuka
- Address
- Scheelevagen 19 Ideon Science Park Lund SE SE 223-70 SE 223-70
FDA Registration Numbers#
- 3005304945
- 3004681519
- 3010413864
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QRR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234008 | CERAMENT G | Bonesupport AB | 2024-03-13 |