FDA applicant

Sierra Surgical, Inc.

Rancho Cordova, CA1 decision1991–19911 recall

FDA records 1 decision for Sierra Surgical, Inc. (Rancho Cordova, CA) in 1991: 1 510(k) clearance. All are in product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic…). 1 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 Sierra Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sierra Surgical, Inc. since 2007.

Recalls per year

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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See the 510(k) Report

Other applicant names beginning “Sierra”

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

Sierra Laboratories, Inc. 12 Sierra Scientific Instruments, Inc. 2 Sierra Medical Devices 2 Sierra Corp. 1 Sierra Diagnostic, LLC 1 Sierra Biosearch, Inc. 1 Sierra Diagnostics 1 Sierra Battery, Inc. 1

Sierra Surgical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sierra”