510(k) Report

FDA applicant

Rdh Medical

Paso Robles, CA1 decision1997–19970 recalls

FDA records 1 decision for Rdh Medical (Paso Robles, CA) in 1997: 1 510(k) clearance. All are in product code HSB (Rod, Fixation, Intramedullary And Accessories). 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 Rdh Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rdh Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rdh Medical’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

Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories1decision

What has FDA decided for it lately?

  • K964444Quicklock Orthopaedic Targeting SystemRdh Medical · 1997

The one decision as Rdh Medical →