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510(k) K231145

Axis Anterior Cervical Plate System by Southern Medical (Pty) , Ltd. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2023
Date Received
April 21, 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

Other clearances by Southern Medical (Pty) , Ltd.

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  • K221182 — Southern Transforaminal Lumbar Interbody Fusion (TLIF) (December 8, 2022)
  • K221447 — Southern Anterior Screw Fixated Cage (SASCA) (October 14, 2022)

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