FDA.report

510(k) K240935

Device
ARENAL Anterior Cervical Plate System
Applicant
Effortmed, LLC
510(k) number
K240935
Product code
KWQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-17
Date received
2024-04-05
Regulation
888.3060
Classification name
Appliance, Fixation, Spinal Intervertebral Body
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Steven Brown
Address
4766 NW 91st Way Coral Springs FL US 33067 33067

FDA Registration Numbers

Source Documents

510(k) summary PDF

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