510(k) Report

FDA applicant

Expanding Innovations, Inc.

Mountain View, CA8 decisions2020–20250 recalls

FDA records 8 decisions for Expanding Innovations, Inc. (Mountain View, CA) from 2020 to 2025: 8 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 83 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 10 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 Expanding Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2020: 12021: 12022: 22023: 12025: 3
2020high 3 (2025) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Expanding Innovations, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Expanding”

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