Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spinal Innovations, 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) |
|---|---|---|---|---|---|
| K022997 | SPECTRUM CERVICAL SPINAL SYSTEM | Spinal Innovations, LLC | 2002-12-06 | 88 | 0 |
| K013196 | ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM | Spinal Innovations, LLC | 2002-01-30 | 127 | 0 |
| K010639 | CONVERGENCE CERVICAL SPINAL SYSTEM | Spinal Innovations, LLC | 2001-05-30 | 86 | 0 |
| K002069 | ASCEND SPINAL FIXATION SYSTEM | Spinal Innovations, LLC | 2000-10-05 | 90 | 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