FDA.report

510(k) K230435

Device
Arthrex 3.9 mm SwiveLock Anchor
Applicant
Arthrex, Inc.
510(k) number
K230435
Product code
MAI
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-17
Date received
2023-02-17
Regulation
888.3030
Classification name
Fastener, Fixation, Biodegradable, 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 34113 34113

FDA Registration Numbers

Source Documents

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

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