510(k) K110789
K110789 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES STERNAL ZIPFIX SYSTEM". The FDA issued a decision of Substantially Equivalent on July 28, 2011. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Synthes (Usa) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2011
- Date Received
- March 22, 2011
- 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