Southern Craniomaxillofacial (CMF) System
FDA 510(k) K253373 · Southern Medical (Pty) , Ltd.
510(k) numberK253373
Submission
- Device name
- Southern Craniomaxillofacial (CMF) System
- Applicant
- Southern Medical (Pty) , Ltd.
Irene, ZA - Received
- September 30, 2025
- Decision date
- December 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JEY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…JEY · Traditional | KLS-Martin L.P. | 08/17/2026SE |
| K253206 | METICULY Patient-specific CMF solutionJEY · Traditional | Meticuly Co., Ltd. | 07/25/2026SE |
| K252246 | Leforte MMF SystemJEY · Traditional | Jeil Medical Corporation | 04/02/2026SE |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…JEY · Traditional | Inion OY | 11/07/2025SE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional | KLS-Martin L.P. | 08/16/2024SE |
| K240651 | MRI UniversalJEY · Traditional | Stryker Leibinger GmbH & Co KG | 07/12/2024SE |
| K233874 | tmCMF SolutionJEY · Traditional | Techmah Cmf | 07/11/2024SE |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implantJEY · Traditional | Meticuly Co., Ltd. | 04/30/2024SE |
| K232350 | Stryker Facial iD SystemJEY · Traditional | Stryker Craniomaxillofacial | 01/13/2024SE |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemJEY · Traditional | Medcad | 09/26/2023SE |
More from Medcad
| 510(k) | Device | Decision |
|---|---|---|
| K230608 | SPICCA Stand-Alone Cervical Fusion CagesOVE · Traditional | 08/14/2023SE |
| K230607 | SPICCA Cervical Fusion CagesODP · Traditional | 08/14/2023SE |
| K231145 | Axis Anterior Cervical Plate SystemKWQ · Traditional | 06/13/2023SE |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF)MAX · Traditional | 12/08/2022SE |
| K221447 | Southern Anterior Screw Fixated Cage (SASCA)OVD · Traditional | 10/14/2022SE |
Questions and answers
When was Southern Craniomaxillofacial (CMF) System cleared by the FDA?
Southern Craniomaxillofacial (CMF) System (K253373) received a 510(k) decision of Substantially Equivalent on December 19, 2025, 80 days after the submission was received.
What is the product code of K253373?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.