510(k) Report

FDA applicant

Neuro Spinal Innovation, Inc.

Mississauga, CA1 decision2024–20240 recalls

FDA records 1 decision for Neuro Spinal Innovation, Inc. (Mississauga, CA) in 2024: 1 510(k) clearance. All are in product code LXM (Manipulator, Plunger-Like Joint). Its devices cite 1 predicate, 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 Neuro Spinal Innovation, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Neuro Spinal Innovation, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Neuro”

FDA records each applicant name separately; these may or may not be the same firm.