510(k) K231251

FlexWing Anterior Cervical Plate System by Jeil Medical Corporation — Product Code KWQ

K231251 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "FlexWing Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on July 24, 2024. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Jeil Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2024
Date Received
May 1, 2023
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