510(k) Report

FDA applicant

Expanding Orthopedics, Inc.

Colorado Springs, CO3 decisions2009–20171 recall

FDA records 3 decisions for Expanding Orthopedics, Inc. (Colorado Springs, CO) from 2009 to 2017: 3 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 9 predicates, 1 of them its own earlier devices. 1 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 Orthopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009: 12014: 12017: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2009high 1 (2022) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Expanding Orthopedics, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Expanding Orthopedics, 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 “Expanding”

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