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FDA 510(k)

Southern Craniomaxillofacial (CMF) System

K-Number: K253373 · 2025-12-19

ApplicantSouthern Medical (Pty) , Ltd.
Decision Date2025-12-19
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Southern Craniomaxillofacial (CMF) System is a medical device manufactured by Southern Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 2025-12-19 under approval number K253373. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Southern Craniomaxillofacial (CMF) System?

Southern Craniomaxillofacial (CMF) System is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Southern Medical (Pty) , Ltd.. The 510(k) number is K253373.

When was Southern Craniomaxillofacial (CMF) System approved by the FDA?

Southern Craniomaxillofacial (CMF) System received FDA 510(k) clearance on 2025-12-19, under approval number K253373.

What company makes Southern Craniomaxillofacial (CMF) System?

Southern Craniomaxillofacial (CMF) System is manufactured by Southern Medical (Pty) , Ltd..

What is the FDA product code for Southern Craniomaxillofacial (CMF) System?

The FDA product code for Southern Craniomaxillofacial (CMF) System is JEY.

Other Devices by Southern Medical (Pty) , Ltd.

K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF) K221447Southern Anterior Screw Fixated Cage (SASCA) K230607SPICCA Cervical Fusion Cages K230608SPICCA Stand-Alone Cervical Fusion Cages K231145Axis Anterior Cervical Plate System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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