FDA.report

510(k) K260228

Device
POYA 3.5mm Medial Proximal Tibia System
Applicant
Bonebridge AG
510(k) number
K260228
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-24
Date received
2026-01-26
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
Michelle Gumpelmayer
Address
Bahnhofstrasse 11 Zug CH 6300 6300

FDA Registration Numbers

Source Documents

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

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