FDA.report

510(k) K222263

Device
Arthrex Self Punching SwiveLock Suture Anchors
Applicant
Arthrex Inc.
510(k) number
K222263
Product code
MAI  
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-26
Date received
2022-07-28
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
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Tiffany Mentzel
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

Legacy Summary

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FDA Review

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