Atlas FDA

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

Spinal Simplicity, LLC — Predicate Candidate Screening

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

152 daysmedian FDA review time
366 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC2025-12-01630
K250001Patriot SI Implant SystemSpinal Simplicity, LLC2025-06-031520
K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC2024-05-24840
K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC2024-04-192630
K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior FusionSpinal Simplicity, LLC2024-01-18280
K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC2023-12-051580
K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior FusioSpinal Simplicity, LLC2023-11-29280
K221307Edge Upper Cervical SystemSpinal Simplicity, LLC2023-07-104310
K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman Spinal Simplicity, LLC2022-08-191350
K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC2022-03-112630
K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman Spinal Simplicity, LLC2021-12-151050
K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC2020-12-103320
K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC2015-08-20550
K140046SPINOUS PROCESS FUSION (SPF) PLATESpinal Simplicity, LLC2015-01-093660

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