Clearance Summary
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES received FDA 510(k) clearance under submission number K070561, sponsored by Teleflex Medical. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-05-25.
- Submission: K070561
- Applicant / Sponsor: Teleflex Medical
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2007-05-25
Classification & Regulation
This clearance is catalogued under FDA product code HTY and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.