Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Southern Spine, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211845 | Deploy Expandable Interbody System | Southern Spine, LLC | 2021-11-16 | 154 | 0 |
| K130948 | C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | Southern Spine, LLC | 2013-08-14 | 131 | 0 |
| K123093 | STABILINK MIS SPINAL FIXATION SYSTEM | Southern Spine, LLC | 2012-12-20 | 79 | 0 |
| K063764 | SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- | Southern Spine, LLC | 2007-05-16 | 147 | 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