FDA applicant

Aegis Spine, Inc.

Englewood, CO6 decisions2021–20230 recalls

FDA records 6 decisions for Aegis Spine, Inc. (Englewood, CO) from 2021 to 2023: 6 510(k) clearances. Most are in product codes OUR (Sacroiliac Joint Fixation) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Aegis Spine”.

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 Aegis Spine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2021high 2 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Aegis Spine, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aegis Spine, Inc.’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 “Aegis”

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

Aegis Surgical, Ltd. 2 Aegis Medical Systems, Inc. 1

Aegis Spine, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “Aegis”