FDA applicant

Spinal USA

Pear, MS24 decisions2006–20130 recalls

FDA records 24 decisions for Spinal USA (Pear, MS) from 2006 to 2013: 24 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 73 predicates, 25 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Spinal USA, LLC”.

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

FDA decisions per year

5in 2013

2007high 6 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

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 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 Alignment Solutions, Inc. 2

Spinal USA

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”