510(k) K230141

LOQTEQ® VA Elbow Plates 2.7/3.5 System by Aap Implantate AG — Product Code HRS

K230141 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "LOQTEQ® VA Elbow Plates 2.7/3.5 System". The FDA issued a decision of Substantially Equivalent on March 17, 2023. 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
March 17, 2023
Date Received
January 18, 2023
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