510(k) K240935

ARENAL Anterior Cervical Plate System by Effortmed, LLC — Product Code KWQ

K240935 is an FDA 510(k) premarket notification submitted by Effortmed, LLC for the device "ARENAL Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on May 17, 2024. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Effortmed, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2024
Date Received
Apr 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type