Clearance Summary
SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS received FDA 510(k) clearance under submission number K090686, sponsored by Sic Brevetti S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-12-08.
- Submission: K090686
- Applicant / Sponsor: Sic Brevetti S.R.L.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3010
- Decision date: 2009-12-08
Classification & Regulation
This clearance is catalogued under FDA product code JDQ and 21 CFR 888.3010, within the Orthopedic review panel as a Class II device.