Clearance Summary
REPROCESSED EXTERNAL FIXATION DEVICE received FDA 510(k) clearance under submission number K061759, sponsored by Ascent Healthcare Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-09-05.
- Submission: K061759
- Applicant / Sponsor: Ascent Healthcare Solutions
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2006-09-05
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.