FDA applicant

Spinal Solutions, LLC

Round Rock, TX1 decision2011–20118 recalls

FDA records 1 decision for Spinal Solutions, LLC (Round Rock, TX) in 2011: 1 510(k) clearance. All are in product code MNH (Orthosis, Spondylolisthesis Spinal Fixation). Its devices cite 2 predicates, 0 of them its own earlier devices. 8 recalls are 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 Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

8in 2013

2011high 8 (2013) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Spinal Solutions, LLC by year, 2011–2026Sources: 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 Devices, LLC 2 Spinal Balance, Inc. 2 Spinal Analytics & Geometrical Implant Co, LLC 2

Spinal Solutions, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Spinal”