510(k) K141823

AAP LOQTEC CLAVICLE PLATES 2.7/3.5 by Aap Implantate AG — Product Code HRS

K141823 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "AAP LOQTEC CLAVICLE PLATES 2.7/3.5". The FDA issued a decision of Substantially Equivalent on August 7, 2014. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Aap Implantate AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2014
Date Received
July 7, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type