FDA.report

510(k) K220839

Device
Arthrex Compression FT Pins
Applicant
Arthrex, Inc.
510(k) number
K220839
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-19
Date received
2022-03-23
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
Rebecca R. Homan
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

Other 510(k) Records For Product Code HWC

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K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics2026-04-10
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K252901Tyber Medical Trauma ScrewTyber Medical, LLC2025-12-31
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K250536MetaFore Small Screw SystemExtremity Medical, LLC2025-10-08
K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025-10-02
K252019CurvaFix Low Profile SystemCurvafix, Inc.2025-08-29
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.2025-08-27