510(k) Report

FDA applicant

Onyx Medical Corp.

Memphis, TN48 decisions1990–20040 recalls

FDA records 48 decisions for Onyx Medical Corp. (Memphis, TN) from 1990 to 2004: 48 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). No recall is linked to its devices.

FDA’s records also spell it “Onyx Medical, Inc.”.

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 Onyx Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Onyx Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Onyx 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

Other applicant names beginning “Onyx”

FDA records each applicant name separately; these may or may not be the same firm.