510(k) K131459

AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE by Aap Implantate AG — Product Code JDW

K131459 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE". The FDA issued a decision of Substantially Equivalent on October 17, 2013. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Aap Implantate AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2013
Date Received
May 20, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type