510(k) K102834

ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) by Kinamed, Incorporated — Product Code JDQ

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