Clearance Summary
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES received FDA 510(k) clearance under submission number K032058, sponsored by Alliance Medical Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-07-30.
- Submission: K032058
- Applicant / Sponsor: Alliance Medical Corp.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2003-07-30
Classification & Regulation
This clearance is catalogued under FDA product code KTT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.