FDA applicant

Clinitex Medical Corp.

Huntersville, NC2 decisions1997–19970 recalls

FDA records 2 decisions for Clinitex Medical Corp. (Huntersville, NC) in 1997: 2 510(k) clearances. All are in product code LGF (Component, Cast). 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 Clinitex Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinitex Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Clinitex Medical Corp.’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

Clinitex Medical Corp.

Which product codes does it file in?

What has FDA decided for it lately?