FDA.reportPublic FDA data

510(k) K242399

Device
Bonebridge Osteosynthesis Plating System
Applicant
Bonebridge AG
510(k) number
K242399
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-31
Date received
2024-08-13
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
No

Applicant Contact#

Contact
Michelle Gumpelmayer
Address
Bahnhofstrasse 11 Zug CH 6300 6300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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