Clearance Summary
BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 received FDA 510(k) clearance under submission number K123081, 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 2013-03-07.
- Submission: K123081
- 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: 2013-03-07
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.