Clearance Summary
FEMORAL INTRAFIX SCREW AND SHEATH received FDA 510(k) clearance under submission number K063577, sponsored by Johnson & Johnson Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-01-25.
- Submission: K063577
- Applicant / Sponsor: Johnson & Johnson Company
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2007-01-25
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.