FDA applicant

Sonoma Orthopedic Products, Inc.

Santa Rosa, CA9 decisions2008–20170 recalls

FDA records 9 decisions for Sonoma Orthopedic Products, Inc. (Santa Rosa, CA) from 2008 to 2017: 9 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HRS (Plate, Fixation, Bone). Its devices cite 13 predicates, 3 of them its own earlier devices. 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 Sonoma Orthopedic Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008high 3 (2008) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Sonoma Orthopedic Products, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sonoma Orthopedic Products, Inc.’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 “Sonoma”

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

Sonoma Pharmaceuticals, Inc. 8 Sonoma Orthopedics Products, Inc. 2

Sonoma Orthopedic Products, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sonoma”