510(k) K090686
K090686 is an FDA 510(k) premarket notification submitted by Sic Brevetti S.R.L. for the device "SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS". The FDA issued a decision of Substantially Equivalent on Dec 8, 2009. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 8, 2009
- Date Received
- Mar 16, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type
- 510(k)