Clearance Summary
DSM Biomedical Calcium Phosphate Cement received FDA 510(k) clearance under submission number K173362, sponsored by Kensey Nash Corporation Dba Dsm Biomedical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-04-03.
- Submission: K173362
- Applicant / Sponsor: Kensey Nash Corporation Dba Dsm Biomedical
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2018-04-03
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.