510(k) Report

FDA applicant

Orthologic Corp.

Phoenix, AZ3 decisions1994–19960 recalls

FDA records 3 decisions for Orthologic Corp. (Phoenix, AZ) from 1994 to 1996: 3 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HTY (Pin, Fixation, Smooth). 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 Orthologic Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthologic Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Orthologic Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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