Data / Medical devices / South Africa / Southern Medical (pty) Ltd
Southern Medical (pty) Ltd: FDA-registered device maker in IRENE Gauteng, South Africa, 6 510(k) clearances
Southern Medical (pty) Ltd is registered with the FDA (registration 3003898943) in IRENE Gauteng, South Africa. It lists 11 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003898943
- Address
- 55 Regency, Route 21 Corporate Park, Irene, Pretoria, IRENE Gauteng, South Africa, 0062
- Owner or operator
- Southern Medical (Pty) Ltd (9052759)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- October 14, 2021
- Registered through
- 2026
- Brand names listed
- Axis, Riven Caspar Distractor, Riven Caspar Pins, SPICCA, SPICCA-SP, Southern Maxillofacial (MF) system, Southern SASCA, Southern TLIF
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Plate, Bone | JEY | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Intraosseous | DZL | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Table, Operating-Room, Electrical | GDC | 1 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2025 | K253373 | Southern Craniomaxillofacial (CMF) System | JEY | Substantially Equivalent | Southern Medical (Pty) , Ltd. | accessdata.fda.gov |
| August 14, 2023 | K230608 | SPICCA Stand-Alone Cervical Fusion Cages | OVE | Substantially Equivalent | Southern Medical (Pty) , Ltd. | accessdata.fda.gov |
| August 14, 2023 | K230607 | SPICCA Cervical Fusion Cages | ODP | Substantially Equivalent | Southern Medical (Pty) , Ltd. | accessdata.fda.gov |
| June 13, 2023 | K231145 | Axis Anterior Cervical Plate System | KWQ | Substantially Equivalent | Southern Medical (Pty) , Ltd. | accessdata.fda.gov |
| December 8, 2022 | K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | MAX | Substantially Equivalent | Southern Medical (Pty) , Ltd. | accessdata.fda.gov |
| October 14, 2022 | K221447 | Southern Anterior Screw Fixated Cage (SASCA) | OVD | Substantially Equivalent | Southern Medical (Pty) , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Bone
- All makers of Screw, Fixation, Intraosseous
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Tray, Surgical, Instrument
Updated December 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.