FDA applicant

Highridge Medical, LLC

Westminister5 decisions2013–20250 recalls

FDA records 5 decisions for Highridge Medical, LLC (Westminister) from 2013 to 2025: 2 510(k) clearances and 3 original PMA approvals. Most are in product codes MJO (Prosthesis, Intervertebral Disc) and NKG (Posterior Cervical Screw System). Its devices cite 3 predicates, 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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Highridge Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Highridge Medical, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Highridge Medical, 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

Highridge Medical, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?