Clearance Summary
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S received FDA 510(k) clearance under submission number K090374, sponsored by DePuy Orthopaedics, 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 2009-03-11.
- Submission: K090374
- Applicant / Sponsor: DePuy Orthopaedics, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2009-03-11
Classification & Regulation
This clearance is catalogued under FDA product code LXT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.