Clearance Summary
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING received FDA 510(k) clearance under submission number K081876, sponsored by Osteomed LP. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2008-08-01.
- Submission: K081876
- Applicant / Sponsor: Osteomed LP
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3730
- Decision date: 2008-08-01
Classification & Regulation
This clearance is catalogued under FDA product code KWD and 21 CFR 888.3730, within the Orthopedic review panel as a Class II device.