Clearance Summary
MODULAR FEMORAL HEAD WITH OFFSET TRUNION received FDA 510(k) clearance under submission number K914675, sponsored by Kirschner Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1992-08-07.
- Submission: K914675
- Applicant / Sponsor: Kirschner Medical Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3350
- Decision date: 1992-08-07
Classification & Regulation
This clearance is catalogued under FDA product code JDI and 21 CFR 888.3350, within the Orthopedic review panel as a Class II device.