FDA applicant

Spinal Devices, LLC

Apple Valley, MN2 decisions2009–20090 recalls

FDA records 2 decisions for Spinal Devices, LLC (Apple Valley, MN) in 2009: 2 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and HRX (Arthroscope). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FDA decisions per year

2in 2009

2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Spinal Devices, LLC by year, 2009–2026Sources: 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 Innovations, LLC 5 Spinal Resources, Inc. 4 Spinal Edge, LLC 3 Spinal Kinetics, LLC 2 Spinal Balance, Inc. 2 Spinal Analytics & Geometrical Implant Co, LLC 2 Spinal Alignment Solutions, Inc. 2

Spinal Devices, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Spinal”