FDA applicant

Cutting Edge Spine, LLC

Waxhaw, NC11 decisions2011–20250 recalls

FDA records 11 decisions for Cutting Edge Spine, LLC (Waxhaw, NC) from 2011 to 2025: 11 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and OUR (Sacroiliac Joint Fixation). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 14 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 Cutting Edge Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2011high 3 (2020) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Cutting Edge Spine, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cutting Edge Spine, LLC’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 “Cutting”

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

Cutting Edge Technologies, Inc. 2

Cutting Edge Spine, LLC

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 “Cutting”