Clearance Summary
PFC SIGMA Knee System received FDA 510(k) clearance under submission number K182301, 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 2019-11-08.
- Submission: K182301
- Applicant / Sponsor: DePuy Orthopaedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2019-11-08
Classification & Regulation
This clearance is catalogued under FDA product code JWH and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.