FDA.reportPublic FDA data

510(k) K231145

Device
Axis Anterior Cervical Plate System
Applicant
Southern Medical (Pty) , Ltd.
510(k) number
K231145
Product code
KWQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-13
Date received
2023-04-21
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
Dalene Styger
Address
55 Regency Dr. Rte. 21 Corporate Park Irene ZA 0178 0178

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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K243904Elegance® Anterior Cervical plateClariance2025-01-14