FDA applicant

Highgate Orthopaedics

Cleveland, OH2 decisions2002–20030 recalls

FDA records 2 decisions for Highgate Orthopaedics (Cleveland, OH) from 2002 to 2003: 2 510(k) clearances. All are in product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). 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 Highgate Orthopaedics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Highgate Orthopaedics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Highgate Orthopaedics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Highgate Orthopaedics

Which product codes does it file in?

What has FDA decided for it lately?