Clearance Summary
BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 received FDA 510(k) clearance under submission number K123225, sponsored by Aap Biomaterials GmbH & Co. KG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-03-15.
- Submission: K123225
- Applicant / Sponsor: Aap Biomaterials GmbH & Co. KG
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2013-03-15
Classification & Regulation
This clearance is catalogued under FDA product code LOD and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.