FDA applicant

Spinal Acoustics, LLC

Beaver, PA1 decision2016–20160 recalls

FDA records 1 decision for Spinal Acoustics, LLC (Beaver, PA) in 2016: 1 510(k) clearance. All are in product code LXM (Manipulator, Plunger-Like Joint). Its devices cite 3 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

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

FDA decisions per year

1in 2016

2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Spinal Acoustics, LLC by year, 2016–2026Sources: 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 Acoustics, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Spinal”