Clearance Summary
MARK I TOTAL KNEE SYS. ARTHROPLASTY received FDA 510(k) clearance under submission number K832302, sponsored by Advanced Biosearch Assn.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1983-08-16.
- Submission: K832302
- Applicant / Sponsor: Advanced Biosearch Assn.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 1983-08-16
Classification & Regulation
This clearance is catalogued under FDA product code MBV and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.