FDA applicant

Spinal Innovations, LLC

Bartlett, TN5 decisions2000–20030 recalls

FDA records 5 decisions for Spinal Innovations, LLC (Bartlett, TN) from 2000 to 2003: 5 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). No recall is linked to its devices.

FDA’s records also spell it “Spinal Innovations, Inc.”.

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 Innovations, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spinal Innovations, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spinal Innovations, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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 Simplicity, LLC 17 Spinal Specialties, Inc. 8 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 Innovations, LLC

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Spinal”