FDA applicant

Spinal Simplicity, LLC

Overland Park, KS17 decisions2015–20260 recalls

FDA records 17 decisions for Spinal Simplicity, LLC (Overland Park, KS) from 2015 to 2026: 17 510(k) clearances. Most are in product codes PEK (Spinous Process Plate) and OUR (Sacroiliac Joint Fixation). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 20 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Spinal Simplicity”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Spinal Simplicity, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2015high 3 (2023) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Spinal Simplicity, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spinal Simplicity, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Spinal”

FDA records each applicant name separately; these may or may not be the same firm.

Spinal Elements, Inc. 50 Spinal Concepts, Inc. 33 Spinal USA 24 Spinal Specialties, Inc. 8 Spinal Innovations, LLC 5 Spinal Resources, Inc. 4 Spinal Edge, LLC 3 Spinal Kinetics, LLC 2 Spinal Devices, LLC 2 Spinal Balance, Inc. 2 Spinal Analytics & Geometrical Implant Co, LLC 2 Spinal Alignment Solutions, Inc. 2

Spinal Simplicity, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Spinal”