FDA.report

510(k) K252807

Device
Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
Applicant
Arthrex, Inc.
510(k) number
K252807
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-12
Date received
2025-09-03
Regulation
888.3030
Classification name
Plate, 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
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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