FDA.report

510(k) K260294

Device
SF Push-in Anchor
Applicant
Surgical Fusion Technologies GmbH
510(k) number
K260294
Product code
MAI
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-27
Date received
2026-01-29
Regulation
888.3030
Classification name
Fastener, Fixation, Biodegradable, Soft Tissue
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
Mayer Joerg
Address
Wagistrasse 6 Schlieren CH 8952 8952

FDA Registration Numbers

Source Documents

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

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