CERAMENT G
FDA 510(k) clearance DEN210044 · decided 2022-05-17
Clearance details
- K-number
- DEN210044
- Device name
- CERAMENT G
- Applicant
- Bonesupport AB
- Decision
- Unknown
- Date received
- 2021-09-28
- Decision date
- 2022-05-17
- Days to decision
- 231 days
- Clearance type
- Direct
- Product code
- QRR
- Device class
- 2
- Regulation number
- 888.3046
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lund, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CERAMENT G (K234008) | Bonesupport AB | 2024-03-13 |
Recalls involving this device
No recalls on record reference this clearance.