FDA.report

510(k) K254253

Device
LOQTEQ® VA Proximal Humerus Plate 3.5
Applicant
Aap Implantate AG
510(k) number
K254253
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-24
Date received
2025-12-29
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Andreas Reuter
Address
Lorenzweg 5 Berlin DE 12099 12099

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.2026-03-17
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