FDA.report

510(k) K254176

Device
SINEFIX
Applicant
BAAT Medical Products B.V.
510(k) number
K254176
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-16
Date received
2025-12-23
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jasper Springer
Address
F. Hazemeijerstraat 800 Bldg. A04 Hengelo NL 7555RJ 7555RJ

FDA Registration Numbers

Source Documents

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

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