Clearance Summary
OSTEO-CABLE SLEEVE received FDA 510(k) clearance under submission number K024022, sponsored by Biomet, 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 2003-01-23.
- Submission: K024022
- Applicant / Sponsor: Biomet, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 2003-01-23
Classification & Regulation
This clearance is catalogued under FDA product code HXN and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.