FDA applicant

Alpha Orthopaedics

Hayward, CA3 decisions2008–20120 recalls

FDA records 3 decisions for Alpha Orthopaedics (Hayward, CA) from 2008 to 2012: 3 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 9 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Alpha Orthopaedics, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Alpha Orthopaedics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

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

Planning a device like Alpha Orthopaedics’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 “Alpha”

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

Alpha-Tec Systems, Inc. 18 Alpha Unlimited, Inc. 10 Alpha Omega Engineering, Ltd. 9 Alpha-Omega Services, Inc. 9 Alpha Therapeutic Corp. 8 Alpha-Dent 6 Alpha Omega, Ltd. 5 Alpha Gamma Laboratory 4 Alpha-Bio Tec, Ltd. 4 Alpha Surgical, Inc. 2 Alpha Medical Systems 2 Alpha Dent Implants GmbH 2

Alpha Orthopaedics

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Alpha”