Clearance Summary
CERAMENT G received FDA 510(k) clearance under submission number DEN210044, sponsored by Bonesupport AB. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-05-17.
- Submission: DEN210044
- Applicant / Sponsor: Bonesupport AB
- Clearance pathway: Direct
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3046
- Decision date: 2022-05-17
Classification & Regulation
This clearance is catalogued under FDA product code QRR and 21 CFR 888.3046, within the Orthopedic review panel as a Class II device.