Atlas FDA

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

Eminent Spine — Predicate Candidate Screening

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

108 daysmedian FDA review time
325 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250894Eminent Spine Posterior SI SystemEminent Spine2025-10-071960
K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine2025-04-283250
K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine2024-09-03500
K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine2023-02-065300
K221936Standalone ALIF Interbody Fusion SystemEminent Spine2022-10-171080
K143365Eminent Foot Plate SystemEminent Spine2015-03-301260
K133194DIAMOND RATTLESNAKE SYSTEMEminent Spine2014-06-262520
K103068KING COBRA ANTERIOR CERVICAL PLATEEminent Spine2011-01-14880
K100377DIAMONDBACK SPINAL SYSTEMEminent Spine2010-04-22690
K090415EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEMEminent Spine2009-06-011031
K090064EMINENT SPINE INTERBODY FUSION SYSTEMEminent Spine2009-04-09901

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