Clearance Summary
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX received FDA 510(k) clearance under submission number K043061, sponsored by Zimmer Trabecular. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-11-23.
- Submission: K043061
- Applicant / Sponsor: Zimmer Trabecular
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2004-11-23
Classification & Regulation
This clearance is catalogued under FDA product code KWS and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.