Clearance Summary
FORMAGRAFT COLLAGEN BONE GRAFT MATRIX received FDA 510(k) clearance under submission number K050789, sponsored by R and D Medical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-05-27.
- Submission: K050789
- Applicant / Sponsor: R and D Medical, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2005-05-27
Classification & Regulation
This clearance is catalogued under FDA product code MQV and 21 CFR 888.3045, within the Orthopedic review panel as a Class II device.