Clearance Summary
REFIX INTERNAL FRACTURE FIXATION SCREWS received FDA 510(k) clearance under submission number K050388, sponsored by Xtremi-T, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-09-07.
- Submission: K050388
- Applicant / Sponsor: Xtremi-T, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2005-09-07
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.