FDA.report

510(k) K240815

Device
Arthrex Cannulated Screw System
Applicant
Arthrex, Inc.
510(k) number
K240815
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-13
Date received
2024-03-25
Regulation
888.3040
Classification name
Screw, Fixation, Bone
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
Jessica Kim
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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