Clearance Summary
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY received FDA 510(k) clearance under submission number K130498, sponsored by Bacterin International, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-05-31.
- Submission: K130498
- Applicant / Sponsor: Bacterin International, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2013-05-31
Classification & Regulation
This clearance is catalogued under FDA product code MBP and 21 CFR 888.3045, within the Orthopedic review panel as a Class II device.