FDA.report

510(k) K253027

Device
Anchor with Fiber Wire and Disposable Inserter
Applicant
Ortobio S.A.
510(k) number
K253027
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-06
Date received
2025-09-19
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, 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
Arthur Murakami
Address
Avenida Mauá, Nº1133 – Zona 03 Maringá BR 87050020 87050020

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code MBI

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K260561Arthrex FiberTak Suture AnchorArthrex, Inc.2026-03-20
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K251750Trax EX AnchorTrax Surgical, Inc.2026-03-12
K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC2026-03-11
K260405FiberTape ButtonArthrex, Inc.2026-03-09
K253538TeKBrace Knotless AnchorTheramicro2026-03-06
K254306Aevumed FENIX Suture AnchorAevumed, Inc.2026-03-04
K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.2026-03-02
K253695LigaMendRiverpoint Medical, LLC2026-02-27
K253763Y-Knotless™ Flex AnchorsConmed Corporation2026-01-29
K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.2026-01-28