FDA.reportPublic FDA data

510(k) K232256

Device
Alcantara Thoracolumbar Plate System
Applicant
Camber Spine Technologies, LLC
510(k) number
K232256
Product code
KWQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-16
Date received
2023-07-28
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
No

Applicant Contact#

Contact
Brooks McAdam
Address
501 Allendale Rd. King Of Prussia PA US 19406 19406

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWQ#

510(k), Device, Applicant table
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K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.2025-05-23
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K243904Elegance® Anterior Cervical plateClariance2025-01-14