Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Evolution Spine — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

59 daysmedian FDA review time
209 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K262094E3D™-C Interbody SystemEvolution Spine2026-07-22300
K260038E3D™-C Interbody SystemEvolution Spine2026-02-04290
K250167Evolution Spine Navigation InstrumentsEvolution Spine2025-08-182090
K241846E3D™-C Interbody SystemEvolution Spine2024-08-12470
K240368E3D™-A Interbody SystemEvolution Spine2024-05-15990
K232432E3D™-A Interbody SystemEvolution Spine2024-01-301720
K223146EVOLUTION SPINE Interbody SystemEvolution Spine2023-02-071250
K220275EMERGE Anterior Cervical Plate SystemEvolution Spine2022-03-18460
K212405EMERGE™ Anterior Cervical Plate SystemEvolution Spine2021-09-30590

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