FDA.report

510(k) K253895

Device
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
Applicant
Arthrex, Inc.
510(k) number
K253895
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-30
Date received
2025-12-04
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
Stacy Valdez
Address
1370 Creekside Blvd. Naples FL US 34108 34108

FDA Registration Numbers

Source Documents

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

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K251750Trax EX AnchorTrax Surgical, Inc.2026-03-12
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K260405FiberTape ButtonArthrex, Inc.2026-03-09
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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