FDA applicant

Sonoma Orthopedics Products, Inc.

Santa Rosa, CA2 decisions2015–20160 recalls

FDA records 2 decisions for Sonoma Orthopedics Products, Inc. (Santa Rosa, CA) from 2015 to 2016: 2 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 4 predicates, 0 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 Orthopedics Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Sonoma Orthopedics Products, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sonoma Orthopedics Products, Inc.’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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Other applicant names beginning “Sonoma”

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

Sonoma Orthopedic Products, Inc. 9 Sonoma Pharmaceuticals, Inc. 8

Sonoma Orthopedics 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”