510(k) K232256

Alcantara Thoracolumbar Plate System by Camber Spine Technologies, LLC — Product Code KWQ

K232256 is an FDA 510(k) premarket notification submitted by Camber Spine Technologies, LLC for the device "Alcantara Thoracolumbar Plate System". The FDA issued a decision of Substantially Equivalent on April 16, 2024. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Camber Spine Technologies, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2024
Date Received
July 28, 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