Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Southern Medical (Pty) , Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
227 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | 2025-12-19 | 80 | 0 |
| K230607 | SPICCA Cervical Fusion Cages | Southern Medical (Pty) , Ltd. | 2023-08-14 | 164 | 0 |
| K230608 | SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty) , Ltd. | 2023-08-14 | 164 | 0 |
| K231145 | Axis Anterior Cervical Plate System | Southern Medical (Pty) , Ltd. | 2023-06-13 | 53 | 0 |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Southern Medical (Pty) , Ltd. | 2022-12-08 | 227 | 0 |
| K221447 | Southern Anterior Screw Fixated Cage (SASCA) | Southern Medical (Pty) , Ltd. | 2022-10-14 | 149 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda