510(k) K182785

LOQTEQ VA Foot Plates 2.5 by Aap Implantate AG — Product Code HRS

K182785 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "LOQTEQ VA Foot Plates 2.5". The FDA issued a decision of Substantially Equivalent on June 19, 2019. 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
June 19, 2019
Date Received
October 1, 2018
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