Clearance Summary
IFS BONE FIXATION DEVICES received FDA 510(k) clearance under submission number K071035, sponsored by Internal Fixation Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-08-13.
- Submission: K071035
- Applicant / Sponsor: Internal Fixation Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2007-08-13
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.