Clearance Summary
PARKE-DAVIS TOTAL KNEE PROSTHESIS received FDA 510(k) clearance under submission number K800363, sponsored by Warner-Lambert Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1980-03-10.
- Submission: K800363
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4150
- Decision date: 1980-03-10
Classification & Regulation
This clearance is catalogued under FDA product code KTZ and 21 CFR 888.4150, within the Orthopedic review panel as a Class I device.