Clearance Summary
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis received FDA 510(k) clearance under submission number K160071, sponsored by Biomet, 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 2016-06-16.
- Submission: K160071
- Applicant / Sponsor: Biomet, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2016-06-16
Classification & Regulation
This clearance is catalogued under FDA product code MBB and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.