Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectrum 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) |
|---|---|---|---|---|---|
| K201024 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, LLC | 2021-04-29 | 374 | 0 |
| K173518 | Spectrum Spine Expandable Cages (SSEC) | Spectrum Spine, LLC | 2019-03-07 | 478 | 0 |
| K132126 | SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM | Spectrum Spine, LLC | 2013-10-28 | 110 | 0 |
| K122822 | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM | Spectrum Spine, LLC | 2013-02-07 | 146 | 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