510(k) K102834
K102834 is an FDA 510(k) premarket notification submitted by Kinamed, Incorporated for the device "ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)". The FDA issued a decision of Substantially Equivalent on January 12, 2011. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Kinamed, Incorporated has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2011
- Date Received
- September 29, 2010
- Clearance Type
- Special
- 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