Clearance Summary
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT received FDA 510(k) clearance under submission number K053445, sponsored by DePuy Orthopaedics, 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 2006-01-06.
- Submission: K053445
- Applicant / Sponsor: DePuy Orthopaedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2006-01-06
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.