Clearance Summary
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 received FDA 510(k) clearance under submission number K091453, sponsored by DePuy Orthopaedics, 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 2009-08-12.
- Submission: K091453
- Applicant / Sponsor: DePuy Orthopaedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3510
- Decision date: 2009-08-12
Classification & Regulation
This clearance is catalogued under FDA product code KRO and 21 CFR 888.3510, within the Orthopedic review panel as a Class II device.