Clearance Summary
OSTEOPAL received FDA 510(k) clearance under submission number K030903, sponsored by Heraeus Kulzer 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 2003-09-23.
- Submission: K030903
- Applicant / Sponsor: Heraeus Kulzer GmbH & Co. KG
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2003-09-23
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.