Clearance Summary
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES received FDA 510(k) clearance under submission number K013657, sponsored by Biomet Orthopedics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2001-12-03.
- Submission: K013657
- Applicant / Sponsor: Biomet Orthopedics, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2001-12-03
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.