# Southern Medical (Pty), Ltd.

- Location (FDA's records): Irene, ZA
- FDA decisions: 6 (2022–2025): 6 510(k) clearances
- Product codes: OVE (1), KWQ (1), JEY (1), ODP (1), OVD (1), MAX (1)
- 510(k) review time since 2016: median 164 days, against 97 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 19 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spinal Elements, Inc.: 3 (https://510kreport.com/company/spinal-elements)
- Additive Implants, Inc.: 2 (https://510kreport.com/company/additive-implants)
- Eminent Spine: 2 (https://510kreport.com/company/eminent-spine)
- Zimmer Spine, Inc.: 1 (https://510kreport.com/company/zimmer-spine)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)
- Osteonic Co., Ltd.: 1 (https://510kreport.com/company/osteonic)
- Bespoke Technologies, LLC: 1 (https://510kreport.com/company/bespoke-technologies)
- Neurostructures, Inc.: 1 (https://510kreport.com/company/neurostructures)

## Recent decisions
- K253373: Southern Craniomaxillofacial (CMF) System (Dec 19, 2025)
- K230608: SPICCA Stand-Alone Cervical Fusion Cages (Aug 14, 2023)
- K230607: SPICCA Cervical Fusion Cages (Aug 14, 2023)
- K231145: Axis Anterior Cervical Plate System (Jun 13, 2023)
- K221182: Southern Transforaminal Lumbar Interbody Fusion (TLIF) (Dec 8, 2022)
- K221447: Southern Anterior Screw Fixated Cage (SASCA) (Oct 14, 2022)

Source page: https://510kreport.com/company/southern-medical