Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Evolution Spine, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
252 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182478 | Whistler Modular Pedicle Screw System | Evolution Spine, LLC | 2019-01-15 | 127 | 0 |
| K180755 | Vail ALIF Buttress Plate System | Evolution Spine, LLC | 2018-07-06 | 106 | 0 |
| K173375 | Anterior Cervical Plate System | Evolution Spine, LLC | 2017-12-21 | 55 | 0 |
| K160663 | Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) | Evolution Spine, LLC | 2016-11-16 | 252 | 0 |
| K160324 | Cervical Interbody Fusion System | Evolution Spine, LLC | 2016-05-05 | 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